GUDID 00885074291802

EXTENSION 3708120 1X8 20CM EN

MEDTRONIC, INC.

Neural-tissue electrical stimulation lead
Primary Device ID00885074291802
NIH Device Record Keye9f20f1b-e032-4c02-a89f-7c7334ce2866
Commercial Distribution StatusIn Commercial Distribution
Version Model Number3708120
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
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
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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Length20 Centimeter
Length20 Centimeter
Length20 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100885074291802 [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.

00199150064847 - NA2025-12-22 CUSTOM PACK BB12P57R3 HLO IOM FUS M
00199150064861 - NA2025-12-22 CUSTOM PACK BB12S99R1 EVL NEONAT
00199150065042 - NA2025-12-22 CUSTOM PACK BB8S37R40 HLO PUMP TBL
20199150065244 - NA2025-12-22 CUSTOM PACK 11L77R2 20PK ACC PIGTAI
20199150065268 - NA2025-12-22 CUSTOM PACK BB12G80R3 10PK ACC VAC
00199150065271 - NA2025-12-22 CUSTOM PACK BB7J98R19 EVL 3/8 CIRCU
20199150065343 - NA2025-12-22 CUSTOM PACK 8C82R4 5PK ACC AUTOTRANSFU
20199150065626 - NA2025-12-22 CUSTOM PACK BB12M45R1 2PK PACK D 3/8 Y

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