SD316447

GUDID 10887587078175

Ø1.0MM DRILL BIT - 6MM STOP J-LATCH - 90MM

Synthes GmbH

Fluted surgical drill bit, reusable
Primary Device ID10887587078175
NIH Device Record Keyaeb94c9f-97e0-46aa-955b-52dd3e092eba
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberSD316.447
Catalog NumberSD316447
Company DUNS486711679
Company NameSynthes GmbH
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 Usefalse
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
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110887587078175 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZIDRILL, BONE, POWERED

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10887587078175]

Moist Heat or Steam Sterilization


[10887587078175]

Moist Heat or Steam Sterilization


[10887587078175]

Moist Heat or Steam Sterilization


[10887587078175]

Moist Heat or Steam Sterilization


[10887587078175]

Moist Heat or Steam Sterilization


[10887587078175]

Moist Heat or Steam Sterilization


[10887587078175]

Moist Heat or Steam Sterilization


[10887587078175]

Moist Heat or Steam Sterilization


[10887587078175]

Moist Heat or Steam Sterilization


[10887587078175]

Moist Heat or Steam Sterilization


[10887587078175]

Moist Heat or Steam Sterilization


[10887587078175]

Moist Heat or Steam Sterilization


[10887587078175]

Moist Heat or Steam Sterilization


[10887587078175]

Moist Heat or Steam Sterilization


[10887587078175]

Moist Heat or Steam Sterilization


[10887587078175]

Moist Heat or Steam Sterilization


[10887587078175]

Moist Heat or Steam Sterilization


[10887587078175]

Moist Heat or Steam Sterilization


[10887587078175]

Moist Heat or Steam Sterilization


[10887587078175]

Moist Heat or Steam Sterilization


[10887587078175]

Moist Heat or Steam Sterilization


[10887587078175]

Moist Heat or Steam Sterilization


[10887587078175]

Moist Heat or Steam Sterilization


[10887587078175]

Moist Heat or Steam Sterilization


[10887587078175]

Moist Heat or Steam Sterilization


[10887587078175]

Moist Heat or Steam Sterilization


[10887587078175]

Moist Heat or Steam Sterilization


[10887587078175]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-18
Device Publish Date2022-08-10

Devices Manufactured by Synthes GmbH

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H679310930 - NA2025-10-01 SMALL CHUCK WITH KEY
10886982350190 - NA2025-09-22 2.0MM STRAIGHT PLATE 20 HOLES
10887587078465 - NA2025-09-19 NONRETAINING SCREWDRIVER BLADE FOR 90DEG SCREWDRIVER
10886982349873 - NA2025-09-01 CANNULATED CIRCULAR REAMER 16MM
10886982349880 - NA2025-09-01 CANNULATED CIRCULAR REAMER 18MM
10886982349897 - NA2025-09-01 CANNULATED CIRCULAR REAMER 20MM
10886982349903 - NA2025-09-01 CANNULATED CIRCULAR REAMER 22MM

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