GUDID 00643169157484

LEAD 3776-60 OCTAD 1X8 BENT STYLT MAN US

MEDTRONIC, INC.

Neural-tissue electrical stimulation lead
Primary Device ID00643169157484
NIH Device Record Keye8e1ea62-52eb-4e81-b1f5-f50beaa1e382
Commercial Distribution StatusIn Commercial Distribution
Version Model Number3776-60
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 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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Length60 Centimeter
Length60 Centimeter
Length60 Centimeter

Operating and Storage Conditions

Handling Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Handling Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Handling Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Handling Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Fahrenheit and 135 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169157484 [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 Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-09-23

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