GUDID 00643169713369

BIT NAV2076K VRT STERILE DRILL BIT 2.9MM

MEDTRONIC SOFAMOR DANEK, INC.

Fluted surgical drill bit, single-use, sterile
Primary Device ID00643169713369
NIH Device Record Key983cde2f-7ff3-486c-84a6-b2531147c5e8
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberNAV2076K
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169713369 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic stereotaxic instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-22
Device Publish Date2016-08-29

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

00763000864736 - T2 STRATOSPHERE™ Expandable Corpectomy System2025-03-31 INSERTER NAV4360120 20MM/25MM INSERTER
00199150001682 - Medtronic Reusable Instruments2025-03-28 ADAPTER EX5598045 BREAKOFF DRIVER
00763000987343 - Medtronic Reusable Instruments2025-03-28 DRIVER X5485903 MDLX REDUCER
00763000988395 - Medtronic Reusable Instruments2025-03-28 DRIVER X5598043 MDLX PROVISIONAL
00763000663506 - ZEVO™ Anterior Cervical Plate System2025-03-25 PLATE 3002033 ZEVO 33MM 2 LVL
00763000663513 - ZEVO™ Anterior Cervical Plate System2025-03-25 PLATE 3002035 ZEVO 35MM 2 LVL
00763000663872 - ZEVO™ Anterior Cervical Plate System2025-03-25 PLATE G3003059 ZEVO 59MM 3 LVL
00763000663889 - ZEVO™ Anterior Cervical Plate System2025-03-25 PLATE G3003061 ZEVO 61MM 3 LVL

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