SD03010496

GUDID 10886982348265

XL IM REDUCTION TOOL CURVED WITH AO REAMER COUPLING

Synthes GmbH

Orthopaedic bone-reduction tool
Primary Device ID10886982348265
NIH Device Record Key0a7d76a1-5ea9-4def-8165-17c3a086f153
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberSD03.010.496
Catalog NumberSD03010496
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
GS110886982348265 [Primary]

FDA Product Code

LXHOrthopedic manual surgical instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10886982348265]

Moist Heat or Steam Sterilization


[10886982348265]

Moist Heat or Steam Sterilization


[10886982348265]

Moist Heat or Steam Sterilization


[10886982348265]

Moist Heat or Steam Sterilization


[10886982348265]

Moist Heat or Steam Sterilization


[10886982348265]

Moist Heat or Steam Sterilization


[10886982348265]

Moist Heat or Steam Sterilization


[10886982348265]

Moist Heat or Steam Sterilization


[10886982348265]

Moist Heat or Steam Sterilization


[10886982348265]

Moist Heat or Steam Sterilization


[10886982348265]

Moist Heat or Steam Sterilization


[10886982348265]

Moist Heat or Steam Sterilization


[10886982348265]

Moist Heat or Steam Sterilization


[10886982348265]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-05
Device Publish Date2025-02-25

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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