CHARGING SYS 97754 INSR MRICS 60601-1-11 Medical Device Identification

GUDID 00643169585928

CHARGING SYS 97754 INSR MRICS 60601-1-11

MEDTRONIC, INC.

Analgesic spinal cord electrical stimulation system Analgesic spinal cord electrical stimulation system Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger Noninvasive device battery charger

Primary Device ID	00643169585928
NIH Device Record Key	8fa6a694-3035-480f-97ad-210182456b2e
Commercial Distribution Status	In Commercial Distribution
Version Model Number	97754
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

Operating and Storage Conditions

Storage Environment Temperature	Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Temperature	Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Temperature	Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Temperature	Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Temperature	Between -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Temperature	Between -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Temperature	Between -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Temperature	Between -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Temperature	Between -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Temperature	Between -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Temperature	Between -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Temperature	Between -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Temperature	Between -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Temperature	Between -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Temperature	Between -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Temperature	Between -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Temperature	Between -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Temperature	Between -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Temperature	Between -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Temperature	Between -35 Degrees Celsius and 57 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169585928 [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	3
Public Version Date	2018-07-06
Device Publish Date	2015-09-18

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00763000953638 - NA	2024-05-31 CUSTOM PACK BB12A45R1 SMALL LOOP
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20763000953663 - NA	2024-05-31 CUSTOM PACK BB12G60R 2PK 2PK CHRST TBL
00763000953676 - NA	2024-05-31 CUSTOM PACK BB7B00R26 UW CMAG PK