SD312203

GUDID 10886982348364

1.4MM PARALLEL WIRE GUIDE

Synthes GmbH

Surgical drill guide, reusable
Primary Device ID10886982348364
NIH Device Record Keyd3d9c2c5-cc0c-4728-92fd-e9576e265109
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberSD312.203
Catalog NumberSD312203
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110886982348364 [Primary]

FDA Product Code

FZXGuide, surgical, instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10886982348364]

Moist Heat or Steam Sterilization


[10886982348364]

Moist Heat or Steam Sterilization


[10886982348364]

Moist Heat or Steam Sterilization


[10886982348364]

Moist Heat or Steam Sterilization


[10886982348364]

Moist Heat or Steam Sterilization


[10886982348364]

Moist Heat or Steam Sterilization


[10886982348364]

Moist Heat or Steam Sterilization


[10886982348364]

Moist Heat or Steam Sterilization


[10886982348364]

Moist Heat or Steam Sterilization


[10886982348364]

Moist Heat or Steam Sterilization


[10886982348364]

Moist Heat or Steam Sterilization


[10886982348364]

Moist Heat or Steam Sterilization


[10886982348364]

Moist Heat or Steam Sterilization


[10886982348364]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-02-26
Device Publish Date2025-02-18

Devices Manufactured by Synthes GmbH

07612334226747 - NA2025-07-31 LID 2/3 SIZE STAINLESS STEEL
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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