GUDID 00643169157323

LEAD 3778-60 OCTAD 1X8 BENT STYLT MAN US

MEDTRONIC, INC.

Neural-tissue electrical stimulation lead Neural-tissue electrical stimulation lead
Primary Device ID00643169157323
NIH Device Record Key97dd86d6-323d-4b0d-b6d1-5dbf24f7cc78
Commercial Distribution StatusIn Commercial Distribution
Version Model Number3778-60
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

Device Dimensions

Length60 Centimeter
Length60 Centimeter

Operating and Storage Conditions

Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Handling Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169157323 [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.

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00763000953423 - NA2024-05-31 CUSTOM PACK BB12F51R2 E ASSIST PACK
00763000953614 - NA2024-05-31 CUSTOM PACK HY0A20R46 CHRST NN
00763000953621 - NA2024-05-31 CUSTOM PACK BB11Q49R11 3/8 EC
00763000953638 - NA2024-05-31 CUSTOM PACK BB12A45R1 SMALL LOOP
00763000953645 - NA2024-05-31 CUSTOM PACK BB12A44R2 LRG AV LOOP
20763000953663 - NA2024-05-31 CUSTOM PACK BB12G60R 2PK 2PK CHRST TBL
00763000953676 - NA2024-05-31 CUSTOM PACK BB7B00R26 UW CMAG PK

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