GUDID 00763000140199

COUNTERTORQUE 5580153 4.75

MEDTRONIC SOFAMOR DANEK, INC.

Orthopaedic counter-torque/rod-pushing instrument
Primary Device ID00763000140199
NIH Device Record Key23c0ce9d-03da-4ba0-8d16-d768b2a90df8
Commercial Distribution StatusIn Commercial Distribution
Version Model Number5580153
Company DUNS830350380
Company NameMEDTRONIC SOFAMOR DANEK, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
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 Identifiers

Device Issuing AgencyDevice ID
GS100763000140199 [Primary]

FDA Product Code

HXCWRENCH

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00763000140199]

Moist Heat or Steam Sterilization


[00763000140199]

Moist Heat or Steam Sterilization


[00763000140199]

Moist Heat or Steam Sterilization


[00763000140199]

Moist Heat or Steam Sterilization


[00763000140199]

Moist Heat or Steam Sterilization


[00763000140199]

Moist Heat or Steam Sterilization


[00763000140199]

Moist Heat or Steam Sterilization


[00763000140199]

Moist Heat or Steam Sterilization


[00763000140199]

Moist Heat or Steam Sterilization


[00763000140199]

Moist Heat or Steam Sterilization


[00763000140199]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-15
Device Publish Date2021-11-07

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

00199150002108 - Medtronic Reusable Instruments2025-06-09 SCREWDRIVER X2150100 MT25
00199150002115 - Medtronic Reusable Instruments2025-06-09 RETENTIVE X2151160 SLEEVE
00763000829933 - N/a2025-06-09 TRAY 5597907 SAS SV CEMENT DELIV DRIVER
00763000883461 - N/a2025-06-09 LOCK SLEEVE 7480756T LOCK SLEEVE
00763000883478 - N/a2025-06-09 SHAFT 7480757T MAS CEMENT DELIVERY
00763000883485 - N/a2025-06-09 SHAFT 7480758T SAS CEMENT DELIVERY
00763000884529 - N/A2025-06-09 TAP 7080920 4.0 X 13MM TAP
00763000889012 - ATLANTIS® Anterior Cervical Plate System2025-06-09 SCREW 3125413 4.5 X 13 SELF DRILL FIX

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