SD312204

GUDID 10886982348395

1.6MM PARALLEL WIRE GUIDE

Synthes GmbH

Surgical drill guide, reusable
Primary Device ID10886982348395
NIH Device Record Key47b55b42-70c3-4a09-8df6-24c1c33b8e70
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberSD312.204
Catalog NumberSD312204
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
GS110886982348395 [Primary]

FDA Product Code

FZXGuide, surgical, instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10886982348395]

Moist Heat or Steam Sterilization


[10886982348395]

Moist Heat or Steam Sterilization


[10886982348395]

Moist Heat or Steam Sterilization


[10886982348395]

Moist Heat or Steam Sterilization


[10886982348395]

Moist Heat or Steam Sterilization


[10886982348395]

Moist Heat or Steam Sterilization


[10886982348395]

Moist Heat or Steam Sterilization


[10886982348395]

Moist Heat or Steam Sterilization


[10886982348395]

Moist Heat or Steam Sterilization


[10886982348395]

Moist Heat or Steam Sterilization


[10886982348395]

Moist Heat or Steam Sterilization


[10886982348395]

Moist Heat or Steam Sterilization


[10886982348395]

Moist Heat or Steam Sterilization


[10886982348395]

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

07611819642669 - NA2025-06-27 130 DEG AIMING ARM STATIC+DYNAMIC DISTAL LOCKING
07611819642676 - NA2025-06-27 125 DEG AIMING ARM STATIC+DYNAMIC DISTAL LOCKING
07611819655522 - NA2025-06-27 135 DEG AIMING ARM STATIC+DYNAMIC DISTAL LOCKING
10886982348159 - NA2025-06-27 5.0MM BLUNTED POINT SCHANZ SCREW 45MM THRD/175MM/HA STER
10886982348166 - NA2025-06-27 5.0MM BLUNTED POINT SCHANZ SCREW 45MM THRD/250MM/HA STER
10886982348173 - NA2025-06-27 5.0MM BLUNTED POINT SCHANZ SCREW 50MM THRD/175MM/HA STER
10886982348180 - NA2025-06-27 5.0MM BLUNTED POINT SCHANZ SCREW 50MM THRD/250MM/HA STER
10886982348197 - NA2025-06-27 6.0MM BLUNTED POINT SCHANZ SCREW 45MM THRD/175MM/HA STER

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