NIM9Spine

GUDID 00613994244055

INSTRUMENT 9450067 SURFCE ELECTRD KT 8CH

MEDTRONIC SOFAMOR DANEK, INC.

Nerve-locating system
Primary Device ID00613994244055
NIH Device Record Key2c7244a0-77e8-434d-9aa9-76d2815c4248
Commercial Distribution StatusIn Commercial Distribution
Brand NameNIM9Spine
Version Model Number9450067
Company DUNS830350380
Company NameMEDTRONIC SOFAMOR DANEK, 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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
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
GS100613994244055 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ETNSTIMULATOR, NERVE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-10-01

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

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00763000679682 - POWEREASE™ Instruments2025-08-05 SLEEVE 2343435 15MM SLEEVE
00763000671525 - VERTE-STACK Spinal System2025-08-04 INSERTER 6246011 HANDLE OUTER
00763000674458 - Medtronic Resuable Instruments2025-08-04 FREEHAND HOLDER 9877701 LORDOTIC 3-HOLE
00763000679415 - Medtronic Resuable Instruments2025-08-04 GUIDE 9874133 DBL BARREL 0 DEG
00763000679460 - Medtronic Resuable Instruments2025-08-04 HOLDER 9870001 4HOLE PLATE FREE HAND
00763000679538 - Medtronic Resuable Instruments2025-08-04 PLATE HOLDER 9874640 4 HOLE
00763000679545 - Medtronic Resuable Instruments2025-08-04 HOLDER 9874145 STAND ALONE

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