05001123

GUDID 07611819928909

DRILL/BURR ATTACHMENT FOR 2.35MM SHAFTS

Synthes GmbH

Drilling power tool attachment, basic
Primary Device ID07611819928909
NIH Device Record Keycbee63f4-d20d-4fd7-adc3-cf41e41f1a62
Commercial Distribution StatusIn Commercial Distribution
Version Model Number05.001.123
Catalog Number05001123
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107611819928909 [Direct Marking]
GS110886982129383 [Primary]
HIBCCH679050011230 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ERLDRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07611819928909]

Moist Heat or Steam Sterilization


[07611819928909]

Moist Heat or Steam Sterilization


[07611819928909]

Moist Heat or Steam Sterilization


[07611819928909]

Moist Heat or Steam Sterilization


[07611819928909]

Moist Heat or Steam Sterilization


[07611819928909]

Moist Heat or Steam Sterilization


[07611819928909]

Moist Heat or Steam Sterilization


[07611819928909]

Moist Heat or Steam Sterilization


[07611819928909]

Moist Heat or Steam Sterilization


[07611819928909]

Moist Heat or Steam Sterilization


[07611819928909]

Moist Heat or Steam Sterilization


[07611819928909]

Moist Heat or Steam Sterilization


[07611819928909]

Moist Heat or Steam Sterilization


[07611819928909]

Moist Heat or Steam Sterilization


[07611819928909]

Moist Heat or Steam Sterilization


[07611819928909]

Moist Heat or Steam Sterilization


[07611819928909]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-04-18
Device Publish Date2016-06-30

Devices Manufactured by Synthes GmbH

10886982313690 - VOLT2025-04-03 3.5 VOLT(TM) PROX HUM PLATE 3H/93MM
10886982313706 - VOLT2025-04-03 3.5 VOLT(TM) PROX HUM PLATE 3H/93MM/STERILE
10886982313713 - VOLT2025-04-03 3.5 VOLT(TM) PROX HUM PLATE 5H/119MM
10886982313720 - VOLT2025-04-03 3.5 VOLT(TM) PROX HUM PLATE 5H/119MM/STERILE
10886982313737 - VOLT2025-04-03 3.5 VOLT(TM) PROX HUM PLATE 3H/93MM
10886982313744 - VOLT2025-04-03 3.5 VOLT(TM) PROX HUM PLATE 3H/93MM/STERILE
10886982313751 - VOLT2025-04-03 3.5 VOLT(TM) PROX HUM PLATE 5H/119MM
10886982313768 - VOLT2025-04-03 3.5 VOLT(TM) PROX HUM PLATE 5H/119MM/STERILE

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