GUDID 00643169157422

LEAD 3875-60 OCTAD 1X8 BENT STYLT MAN US

MEDTRONIC, INC.

Analgesic spinal cord electrical stimulation system
Primary Device ID00643169157422
NIH Device Record Keyd6ab5c95-d11a-4c1e-b21c-eadf58f74618
Commercial Distribution StatusIn Commercial Distribution
Version Model Number3875-60
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 Usetrue
Lot Batchtrue
Serial Numberfalse
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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Length60 Centimeter
Length60 Centimeter
Length60 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169157422 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZBSTIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-06-08

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