GUDID 00613994951052

EXT 748951 QUAD IN LINE LZ BLUE WRNCH

MEDTRONIC, INC.

Neural-tissue electrical stimulation lead
Primary Device ID00613994951052
NIH Device Record Key6bd2b7fb-53e7-43bb-b6fb-c8b4e1b50c5a
Commercial Distribution StatusIn Commercial Distribution
Version Model Number748951
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
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
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

Length51 Centimeter
Length51 Centimeter
Length51 Centimeter
Length51 Centimeter
Length51 Centimeter
Length51 Centimeter
Length51 Centimeter
Length51 Centimeter
Length51 Centimeter
Length51 Centimeter
Length51 Centimeter
Length51 Centimeter
Length51 Centimeter
Length51 Centimeter
Length51 Centimeter
Length51 Centimeter
Length51 Centimeter
Length51 Centimeter
Length51 Centimeter
Length51 Centimeter
Length51 Centimeter
Length51 Centimeter
Length51 Centimeter
Length51 Centimeter
Length51 Centimeter
Length51 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994951052 [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.

00199150060467 - NA2025-11-28 CUSTOM PACK BB11Q49R14 EVL 3/8 EC
00199150060627 - NA2025-11-28 CUSTOM PACK BB12M28R9 HLO QHLM-FROS
00199150057177 - NA2025-11-24 CUSTOM PACK BB3Z71R34 HLO PRIMARY
00199150058976 - NA2025-11-24 CUSTOM PACK PDBB12P71R2 HLO HEATT
00199150060122 - NA2025-11-24 CUSTOM PACK BB12S52R1 EVL 3/8 PACK
00763000849801 - Liberant™2025-11-24 CONSOLE LMT-BCU LIBERANT
00763000913069 - InterStim™ SureScan™2025-11-24 LEAD 978A128 ISTM 2.16MM EUMDR EMAN LI08
00763000913083 - InterStim™ SureScan™2025-11-24 LEAD 978A133 ISTM 2.16MM EMAN EUMDR LI08

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