GUDID 00643169157477

LEAD 3776-45 OCTAD 1X8 BNT STYLT EMAN US

MEDTRONIC, INC.

Neural-tissue electrical stimulation lead
Primary Device ID00643169157477
NIH Device Record Key2b613d4f-a516-4269-9fe9-b1f00495d1ef
Commercial Distribution StatusIn Commercial Distribution
Version Model Number3776-45
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

Length45 Centimeter
Length45 Centimeter
Length45 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
GS100643169157477 [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

Devices Manufactured by MEDTRONIC, INC.

00199150006434 - NA2025-04-22 CUSTOM PACK BB11P23R4 LARGO DUAL V
00199150006465 - NA2025-04-22 CUSTOM PACK BB12E01R8 MAINPCK
00199150006618 - NA2025-04-22 CUSTOM PACK BB6N93R9 OSF ADPTR
00199150006861 - NA2025-04-22 CUSTOM PACK BB6Y28R11 CMAG L I V
00199150006878 - NA2025-04-22 CUSTOM PACK BB6Y37R3 CP PRIME
20199150006896 - NA2025-04-22 CUSTOM PACK BB10Y97R1 5PK MANIFOLD
20199150006919 - NA2025-04-22 CUSTOM PACK BB10Y99R1 10PK ARTERIAL Y
00199150006922 - NA2025-04-22 CUSTOM PACK BB11Q27R2 MANIFOLD

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.