03164020

GUDID 07612334216731

DRILL BIT Ø2.5MM QC L 400 MM CALIBR UP TO 120 MM

Synthes GmbH

Fluted surgical drill bit, single-use
Primary Device ID07612334216731
NIH Device Record Keyf4f5d593-8496-413a-9c49-bc748e374a47
Commercial Distribution StatusIn Commercial Distribution
Version Model Number03.164.020
Catalog Number03164020
Company DUNS486711679
Company NameSynthes GmbH
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 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)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS107612334216731 [Direct Marking]
GS110886982311191 [Primary]

FDA Product Code

HTWBIT, DRILL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07612334216731]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-07
Device Publish Date2022-11-29

Devices Manufactured by Synthes GmbH

10886982350435 - NA2026-02-19 HALF BENNETT SMALL/LEFT
10886982350442 - NA2026-02-19 HALF BENNETT SMALL/RIGHT
10886982350459 - NA2026-02-19 HALF BENNETT LARGE/LEFT
10886982350466 - NA2026-02-19 HALF BENNETT LARGE/RIGHT
10886982351579 - NA2026-02-19 SHOULDER HOOK 2.2 MM TIP / 235 MM LENGTH
10886982351661 - NA2026-02-19 T-HANDLE AO CONNECTOR
10886982351678 - NA2026-02-19 T-HANDLE LARGE AO CONNECTOR
10886982361288 - NA2026-02-19 5MM AWL, QC

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