PROG 97740FA MRI FIXED ASSET 60601-1-11 Medical Device Identification

GUDID 00643169585935

PROG 97740FA MRI FIXED ASSET 60601-1-11

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

Primary Device ID	00643169585935
NIH Device Record Key	a6755ca1-2b58-4a11-86fd-42f4f5b87bae
Commercial Distribution Status	In Commercial Distribution
Version Model Number	97740FA
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

Operating and Storage Conditions

Storage Environment Temperature	Between -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment Temperature	Between -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment Temperature	Between -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment Temperature	Between -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Temperature	Between -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Temperature	Between -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Temperature	Between -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Temperature	Between -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Temperature	Between -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Temperature	Between -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Temperature	Between -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Temperature	Between -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Temperature	Between -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Temperature	Between -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Temperature	Between -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Temperature	Between -34 Degrees Celsius and 57 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169585935 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Approval: P840001

FDA Product Code

LGW	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2018-10-22
Device Publish Date	2015-08-14

Devices Manufactured by MEDTRONIC, INC.

00763000951825 - NA	2024-05-31 CUSTOM PACK SSBB12G88R STERILE SMPL
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