05001053

GUDID 07611819167995

DURA GUARD-LONG FOR PEN DRIVE

Synthes GmbH

Surgical instrument guard, reusable
Primary Device ID07611819167995
NIH Device Record Key5e767234-5eaa-48be-8bd1-f44ff3c3190b
Commercial Distribution StatusIn Commercial Distribution
Version Model Number05.001.053
Catalog Number05001053
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
GS107611819167995 [Direct Marking]
GS110886982128805 [Primary]
HIBCCH679050010530 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWEINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07611819167995]

Moist Heat or Steam Sterilization


[07611819167995]

Moist Heat or Steam Sterilization


[07611819167995]

Moist Heat or Steam Sterilization


[07611819167995]

Moist Heat or Steam Sterilization


[07611819167995]

Moist Heat or Steam Sterilization


[07611819167995]

Moist Heat or Steam Sterilization


[07611819167995]

Moist Heat or Steam Sterilization


[07611819167995]

Moist Heat or Steam Sterilization


[07611819167995]

Moist Heat or Steam Sterilization


[07611819167995]

Moist Heat or Steam Sterilization


[07611819167995]

Moist Heat or Steam Sterilization


[07611819167995]

Moist Heat or Steam Sterilization


[07611819167995]

Moist Heat or Steam Sterilization


[07611819167995]

Moist Heat or Steam Sterilization


[07611819167995]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-04-18
Device Publish Date2016-06-30

Devices Manufactured by Synthes GmbH

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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

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