NIM SPINE™

GUDID 20613994470984

ELECTRODE 945DME2002 48IN 1.2M CORKSCREW

MEDTRONIC SOFAMOR DANEK, INC.

Subdermal needle electrode
Primary Device ID20613994470984
NIH Device Record Keyb07192a2-f6ff-4242-9851-c39125a6bf77
Commercial Distribution StatusIn Commercial Distribution
Brand NameNIM SPINE™
Version Model Number945DME2002
Company DUNS830350380
Company NameMEDTRONIC SOFAMOR DANEK, INC.
Device Count2
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 Batchtrue
Serial Numberfalse
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 Identifiers

Device Issuing AgencyDevice ID
GS100613994470980 [Unit of Use]
GS120613994470984 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXZELECTRODE, NEEDLE

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 Date2016-04-17

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

00763000273804 - n/a2025-10-06 SCREWDRIVER 3606201 TORQUE LIMIT SHAFT
00763000875282 - SHILLA™ Growth Guidance System2025-10-06 SCREW 7675430 5.5 SHILLA MAS CANN 4.5X30
00763000884956 - n/a2025-10-06 LOCK SCREW DRIVER 7080930 TRI-FLAT
00885074240695 - n/a2025-09-30 ACCESSORIES 3299003 GRAFT TAMP
00199150026029 - Medtronic Reusable Instruments2025-09-29 COMPRESSOR X0525001 RACK AND PINION
00763000684044 - Medtronic Reusable Instruments2025-09-29 INSTRUMENT 950-146 RULER
00763000856700 - VERTE-STACK® Spinal System2025-09-29 STRUT 6242064 ANATOMIC 16X14X24MM
00763000879563 - ENDOSKELETON® TCS2025-09-29 HANDLE 5210-1016 TCS RATCHETING HANDLE

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