03010502

GUDID H679030105020

13.0MM PROTECTION SLEEVE FOR RAFN RETROGRADE/QC

Synthes GmbH

Orthopaedic implantation sleeve, reusable
Primary Device IDH679030105020
NIH Device Record Keyf4fe2a3c-85d4-4475-b69a-b7ee5162674f
Commercial Distribution StatusIn Commercial Distribution
Version Model Number03.010.502
Catalog Number03010502
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107611819498990 [Direct Marking]
GS110886982069191 [Primary]
HIBCCH679030105020 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H679030105020]

Moist Heat or Steam Sterilization


[H679030105020]

Moist Heat or Steam Sterilization


[H679030105020]

Moist Heat or Steam Sterilization


[H679030105020]

Moist Heat or Steam Sterilization


[H679030105020]

Moist Heat or Steam Sterilization


[H679030105020]

Moist Heat or Steam Sterilization


[H679030105020]

Moist Heat or Steam Sterilization


[H679030105020]

Moist Heat or Steam Sterilization


[H679030105020]

Moist Heat or Steam Sterilization


[H679030105020]

Moist Heat or Steam Sterilization


[H679030105020]

Moist Heat or Steam Sterilization


[H679030105020]

Moist Heat or Steam Sterilization


[H679030105020]

Moist Heat or Steam Sterilization


[H679030105020]

Moist Heat or Steam Sterilization


[H679030105020]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-04-28
Device Publish Date2015-09-14

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07612334227980 - NA2025-07-31 TRAY FOR OPERACE, 1 FROM 2
07612334228352 - NA2025-07-31 TRAY FOR OPERACE, 2 FROM 2
10886982348982 - NA2025-07-24 Ø12.8MM HOLLOW REAMER
10886982349835 - NA2025-07-24 WRENCH / 11MM SLOTTED SOCKET
10886982350121 - NA2025-07-24 FEMORAL GONIOMETER
10886982350152 - NA2025-07-24 5TH MET WIRE GUIDE
10886982350428 - NA2025-07-24 TENS BENDING EXTRACTOR

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