SD02111501

GUDID 80886982341937

1.25MM REDUCTION WIRE 15MM TIP LENGTH

Synthes GmbH

Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use
Primary Device ID80886982341937
NIH Device Record Keyfe2d6da6-8ef2-4e19-b391-8ef69390e844
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberSD02.111.501
Catalog NumberSD02111501
Company DUNS486711679
Company NameSynthes GmbH
Device Count10
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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
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
GS120886982341935 [Primary]
GS180886982341937 [Unit of Use]

FDA Product Code

LXHOrthopedic manual surgical instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[80886982341937]

Moist Heat or Steam Sterilization


[80886982341937]

Moist Heat or Steam Sterilization


[80886982341937]

Moist Heat or Steam Sterilization


[80886982341937]

Moist Heat or Steam Sterilization


[80886982341937]

Moist Heat or Steam Sterilization


[80886982341937]

Moist Heat or Steam Sterilization


[80886982341937]

Moist Heat or Steam Sterilization


[80886982341937]

Moist Heat or Steam Sterilization


[80886982341937]

Moist Heat or Steam Sterilization


[80886982341937]

Moist Heat or Steam Sterilization


[80886982341937]

Moist Heat or Steam Sterilization


[80886982341937]

Moist Heat or Steam Sterilization


[80886982341937]

Moist Heat or Steam Sterilization


[80886982341937]

Moist Heat or Steam Sterilization


[80886982341937]

Moist Heat or Steam Sterilization


[80886982341937]

Moist Heat or Steam Sterilization


[80886982341937]

Moist Heat or Steam Sterilization


[80886982341937]

Moist Heat or Steam Sterilization


[80886982341937]

Moist Heat or Steam Sterilization


[80886982341937]

Moist Heat or Steam Sterilization


[80886982341937]

Moist Heat or Steam Sterilization


[80886982341937]

Moist Heat or Steam Sterilization


[80886982341937]

Moist Heat or Steam Sterilization


[80886982341937]

Moist Heat or Steam Sterilization


[80886982341937]

Moist Heat or Steam Sterilization


[80886982341937]

Moist Heat or Steam Sterilization


[80886982341937]

Moist Heat or Steam Sterilization


[80886982341937]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-08
Device Publish Date2022-08-31

Devices Manufactured by Synthes GmbH

10886982344229 - NA2024-05-13 FOOT - 10MM UPRIGHT REDUCTION CLAMP
10886982344236 - NA2024-05-13 FOOT - 4MM UPRIGHT REDUCTION CLAMP
10886982344243 - NA2024-05-13 HOOK - 4MM UPRIGHT REDUCTION CLAMP
10886982344250 - NA2024-05-13 HOOK - 10MM UPRIGHT REDUCTION CLAMP
10886982346940 - NA2024-05-09 60MM DEPTH PROBE FOR XL25 SCREWS
10886982346933 - NA2024-05-08 EXTENDED MULTI HOLE WIRE GUIDE FOR RFNA
10886982346957 - NA2024-05-08 FNS ANGLED GUIDE 130° W/ WIDER BASE
10887587078359 - NA2024-04-16 MANDIBLE BODY REDUCTION HANDLE

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