03164021

GUDID 07612334216748

DRILL BIT Ø3.5MM QC LENGTH 380 MM

Synthes GmbH

Fluted surgical drill bit, single-use
Primary Device ID07612334216748
NIH Device Record Keydcd95157-ba05-4faa-a1b3-d1fb6006b867
Commercial Distribution StatusIn Commercial Distribution
Version Model Number03.164.021
Catalog Number03164021
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
GS107612334216748 [Direct Marking]
GS110886982311207 [Primary]

FDA Product Code

HTWBIT, DRILL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07612334216748]

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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