GUDID 00763000875770

CNTRL 97745-RFB INTELLIS PTM REFURB US

MEDTRONIC, INC.

Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer Multiple active implantable device programmer

Primary Device ID	00763000875770
NIH Device Record Key	d40fc4ec-5aea-4eaf-9bf8-9321fc79364f
Commercial Distribution Status	In Commercial Distribution
Version Model Number	97745-RFB
Company DUNS	796986144
Company Name	MEDTRONIC, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com

Operating and Storage Conditions

Storage Environment Temperature	Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Temperature	Between -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment Temperature	Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Temperature	Between -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment Temperature	Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Temperature	Between -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment Temperature	Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Temperature	Between -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment Temperature	Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Temperature	Between -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment Temperature	Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Temperature	Between -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment Temperature	Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Temperature	Between -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment Temperature	Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Temperature	Between -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment Temperature	Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Temperature	Between -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment Temperature	Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Temperature	Between -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment Temperature	Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Temperature	Between -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment Temperature	Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Temperature	Between -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment Temperature	Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Temperature	Between -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment Temperature	Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Temperature	Between -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment Temperature	Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Temperature	Between -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment Temperature	Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Temperature	Between -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment Temperature	Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Temperature	Between -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment Temperature	Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Temperature	Between -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment Temperature	Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Temperature	Between -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment Temperature	Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Temperature	Between -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment Temperature	Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Temperature	Between -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment Temperature	Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Temperature	Between -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment Temperature	Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Temperature	Between -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment Temperature	Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Temperature	Between -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment Temperature	Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Temperature	Between -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment Temperature	Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Temperature	Between -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment Temperature	Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Temperature	Between -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment Temperature	Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Temperature	Between -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment Temperature	Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Temperature	Between -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment Temperature	Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Temperature	Between -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment Temperature	Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Temperature	Between -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment Temperature	Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Temperature	Between -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment Temperature	Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Temperature	Between -30 Degrees Celsius and 58 Degrees Celsius
Storage Environment Temperature	Between -22 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment Temperature	Between -30 Degrees Celsius and 58 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000875770 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P840001

FDA Product Code

QRB	Stimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-11-24
Device Publish Date	2023-11-16

Devices Manufactured by MEDTRONIC, INC.

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00763000953423 - NA	2024-05-31 CUSTOM PACK BB12F51R2 E ASSIST PACK
00763000953614 - NA	2024-05-31 CUSTOM PACK HY0A20R46 CHRST NN
00763000953621 - NA	2024-05-31 CUSTOM PACK BB11Q49R11 3/8 EC
00763000953638 - NA	2024-05-31 CUSTOM PACK BB12A45R1 SMALL LOOP
00763000953645 - NA	2024-05-31 CUSTOM PACK BB12A44R2 LRG AV LOOP
20763000953663 - NA	2024-05-31 CUSTOM PACK BB12G60R 2PK 2PK CHRST TBL
00763000953676 - NA	2024-05-31 CUSTOM PACK BB7B00R26 UW CMAG PK