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

10886982313690 - VOLT2025-04-03 3.5 VOLT(TM) PROX HUM PLATE 3H/93MM
10886982313706 - VOLT2025-04-03 3.5 VOLT(TM) PROX HUM PLATE 3H/93MM/STERILE
10886982313713 - VOLT2025-04-03 3.5 VOLT(TM) PROX HUM PLATE 5H/119MM
10886982313720 - VOLT2025-04-03 3.5 VOLT(TM) PROX HUM PLATE 5H/119MM/STERILE
10886982313737 - VOLT2025-04-03 3.5 VOLT(TM) PROX HUM PLATE 3H/93MM
10886982313744 - VOLT2025-04-03 3.5 VOLT(TM) PROX HUM PLATE 3H/93MM/STERILE
10886982313751 - VOLT2025-04-03 3.5 VOLT(TM) PROX HUM PLATE 5H/119MM
10886982313768 - VOLT2025-04-03 3.5 VOLT(TM) PROX HUM PLATE 5H/119MM/STERILE

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.