GUDID 00613994188335

STIMULATOR 37021 EXTERNAL ADVANCED EN

MEDTRONIC, INC.

Analgesic spinal cord electrical stimulation system
Primary Device ID00613994188335
NIH Device Record Keycb551d25-3b7e-4866-875e-8aec15182567
Commercial Distribution Discontinuation2018-09-26
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number37021
Company DUNS796986144
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

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

Operating and Storage Conditions

Handling Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994188335 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LGWSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-10-02
Device Publish Date2014-09-23

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