03632225

GUDID 07611819588646

NAVIGABLE AWL-TAP 7.0MM DUAL CORE/6MM HXC

Synthes GmbH

Bone awl
Primary Device ID07611819588646
NIH Device Record Key09db1be8-9184-4b3a-91f5-ffae9166737a
Commercial Distribution StatusIn Commercial Distribution
Version Model Number03.632.225
Catalog Number03632225
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107611819588646 [Direct Marking]
GS110705034719580 [Primary]
HIBCCH981036322250 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic stereotaxic instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07611819588646]

Moist Heat or Steam Sterilization


[07611819588646]

Moist Heat or Steam Sterilization


[07611819588646]

Moist Heat or Steam Sterilization


[07611819588646]

Moist Heat or Steam Sterilization


[07611819588646]

Moist Heat or Steam Sterilization


[07611819588646]

Moist Heat or Steam Sterilization


[07611819588646]

Moist Heat or Steam Sterilization


[07611819588646]

Moist Heat or Steam Sterilization


[07611819588646]

Moist Heat or Steam Sterilization


[07611819588646]

Moist Heat or Steam Sterilization


[07611819588646]

Moist Heat or Steam Sterilization


[07611819588646]

Moist Heat or Steam Sterilization


[07611819588646]

Moist Heat or Steam Sterilization


[07611819588646]

Moist Heat or Steam Sterilization


[07611819588646]

Moist Heat or Steam Sterilization


[07611819588646]

Moist Heat or Steam Sterilization


[07611819588646]

Moist Heat or Steam Sterilization


[07611819588646]

Moist Heat or Steam Sterilization


[07611819588646]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-04-26
Device Publish Date2016-06-30

Devices Manufactured by Synthes GmbH

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07612334268587 - KINCISE2024-11-08 KINCISE(TM) SYSTEM STERILIZATION CASE LID
07612334268679 - KINCISE2024-11-08 KINCISE(TM) SYSTEM PRIMARY HIP ADAPTER CASE
07612334268563 - KINCISE2024-11-04 KINCISE™ System Automated Surgical Handpiece V2
07612334268570 - KINCISE2024-11-04 KINCISE™ System Lithium-ion Battery
07612334268594 - KINCISE2024-11-04 KINCISE™ System Primary Hip PINNACLE™ Straight Shell/Liner Impactor - Long
07612334268600 - KINCISE2024-11-04 KINCISE™ System Primary Hip PINNACLE™ Offset Shell/Liner Impactor
07612334268617 - KINCISE2024-11-04 KINCISE™ System Primary Hip PINNACLE™ Inclination Guide

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