3597-6-090

GUDID 07613327084092

Kirschner Wire, Diamond Point

Stryker Trauma SA

Orthopaedic bone wire
Primary Device ID07613327084092
NIH Device Record Keyfe7f9df9-b19b-40d0-b812-e7e54cb8789e
Commercial Distribution StatusIn Commercial Distribution
Version Model Number3597-6-090
Catalog Number3597-6-090
Company DUNS481999654
Company NameStryker Trauma SA
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 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

Device Dimensions

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Length230 Millimeter
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Length230 Millimeter
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Length230 Millimeter
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Length230 Millimeter
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Length230 Millimeter
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Length230 Millimeter
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Length230 Millimeter
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Length230 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327084092 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HTYPIN, FIXATION, SMOOTH
JDWPin, Fixation, Threaded

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


[07613327084092]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-25
Device Publish Date2018-09-24

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07613327603118 - REUNION2024-10-09 Modular Glenoid Surface Trial
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07613327603132 - REUNION2024-10-09 Modular Humeral Head Trial
07613327603149 - REUNION2024-10-09 Modular Glenoid Surface Trial
07613327603156 - REUNION2024-10-09 Modular Humeral Head Trial

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