03617970

GUDID 07611819969766

CANCELLOUS BONE IMPACTOR

Synthes GmbH

Orthopaedic implant impactor
Primary Device ID07611819969766
NIH Device Record Key3176ade5-b822-4fdc-bf06-37a214fdf157
Commercial Distribution StatusIn Commercial Distribution
Version Model Number03.617.970
Catalog Number03617970
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS107611819969766 [Direct Marking]
GS110705034717319 [Primary]
HIBCCH981036179700 [Secondary]

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07611819969766]

Moist Heat or Steam Sterilization


[07611819969766]

Moist Heat or Steam Sterilization


[07611819969766]

Moist Heat or Steam Sterilization


[07611819969766]

Moist Heat or Steam Sterilization


[07611819969766]

Moist Heat or Steam Sterilization


[07611819969766]

Moist Heat or Steam Sterilization


[07611819969766]

Moist Heat or Steam Sterilization


[07611819969766]

Moist Heat or Steam Sterilization


[07611819969766]

Moist Heat or Steam Sterilization


[07611819969766]

Moist Heat or Steam Sterilization


[07611819969766]

Moist Heat or Steam Sterilization


[07611819969766]

Moist Heat or Steam Sterilization


[07611819969766]

Moist Heat or Steam Sterilization


[07611819969766]

Moist Heat or Steam Sterilization


[07611819969766]

Moist Heat or Steam Sterilization


[07611819969766]

Moist Heat or Steam Sterilization


[07611819969766]

Moist Heat or Steam Sterilization


[07611819969766]

Moist Heat or Steam Sterilization


[07611819969766]

Moist Heat or Steam Sterilization


[07611819969766]

Moist Heat or Steam Sterilization


[07611819969766]

Moist Heat or Steam Sterilization


[07611819969766]

Moist Heat or Steam Sterilization


[07611819969766]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-12-02
Device Publish Date2019-08-10

Devices Manufactured by Synthes GmbH

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10886982362193 - NA2026-01-19 CALIBRATION UNIT RFNA PROXIMAL AIMING DEVICE
10886982362209 - NA2026-01-19 ANGULAR ADJUSTMENT LOCK KNOB RFNA PROXIMAL AIMING DEVICE
10886982362216 - NA2026-01-19 LINEAR ADJUSTMENT LOCK KNOB RFNA PROXIMAL AIMING DEVICE
10886982361257 - VOLT2025-12-24 REPLACEMENT BRKTS F/60.529.005
H9810460002902S0 - NA2025-12-11 TI DISTRACTOR PINS-16MM STERILE
H9810460002910S0 - NA2025-12-11 TI DISTRACTOR PINS-16MM STERILE
07612334270139 - EXPert Nail2025-10-02 TRAY F/TIBIAL NAIL EX SP INSTR

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