92-10543

GUDID 07613327589207

3-D PLATE, OBLIQUE

Stryker Leibinger GmbH & Co. KG

Craniofacial fixation plate, non-bioabsorbable
Primary Device ID07613327589207
NIH Device Record Key03f944e1-8767-464c-9c61-4644c8f37203
Commercial Distribution StatusIn Commercial Distribution
Version Model Number92-10543
Catalog Number92-10543
Company DUNS316153956
Company NameStryker Leibinger GmbH & Co. KG
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Angle30 degree
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Angle30 degree
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Angle30 degree
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Angle30 degree
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Angle30 degree
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Angle30 degree
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Angle30 degree
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Angle30 degree
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Angle30 degree
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Angle30 degree
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Angle30 degree
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Angle30 degree
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Angle30 degree
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Angle30 degree
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Angle30 degree
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Angle30 degree
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Angle30 degree
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Angle30 degree
Device Size Text, specify0
Angle30 degree
Device Size Text, specify0
Angle30 degree
Device Size Text, specify0
Angle30 degree
Device Size Text, specify0
Angle30 degree
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Angle30 degree
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Angle30 degree
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Angle30 degree
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Angle30 degree
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Angle30 degree
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Angle30 degree
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Angle30 degree
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Angle30 degree
Device Size Text, specify0
Angle30 degree
Device Size Text, specify0
Angle30 degree
Device Size Text, specify0
Angle30 degree
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Angle30 degree
Device Size Text, specify0
Angle30 degree
Device Size Text, specify0
Angle30 degree
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Angle30 degree
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Device Identifiers

Device Issuing AgencyDevice ID
GS107613327589207 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JEYPLATE, BONE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07613327589207]

Moist Heat or Steam Sterilization


[07613327589207]

Moist Heat or Steam Sterilization


[07613327589207]

Moist Heat or Steam Sterilization


[07613327589207]

Moist Heat or Steam Sterilization


[07613327589207]

Moist Heat or Steam Sterilization


[07613327589207]

Moist Heat or Steam Sterilization


[07613327589207]

Moist Heat or Steam Sterilization


[07613327589207]

Moist Heat or Steam Sterilization


[07613327589207]

Moist Heat or Steam Sterilization


[07613327589207]

Moist Heat or Steam Sterilization


[07613327589207]

Moist Heat or Steam Sterilization


[07613327589207]

Moist Heat or Steam Sterilization


[07613327589207]

Moist Heat or Steam Sterilization


[07613327589207]

Moist Heat or Steam Sterilization


[07613327589207]

Moist Heat or Steam Sterilization


[07613327589207]

Moist Heat or Steam Sterilization


[07613327589207]

Moist Heat or Steam Sterilization


[07613327589207]

Moist Heat or Steam Sterilization


[07613327589207]

Moist Heat or Steam Sterilization


[07613327589207]

Moist Heat or Steam Sterilization


[07613327589207]

Moist Heat or Steam Sterilization


[07613327589207]

Moist Heat or Steam Sterilization


[07613327589207]

Moist Heat or Steam Sterilization


[07613327589207]

Moist Heat or Steam Sterilization


[07613327589207]

Moist Heat or Steam Sterilization


[07613327589207]

Moist Heat or Steam Sterilization


[07613327589207]

Moist Heat or Steam Sterilization


[07613327589207]

Moist Heat or Steam Sterilization


[07613327589207]

Moist Heat or Steam Sterilization


[07613327589207]

Moist Heat or Steam Sterilization


[07613327589207]

Moist Heat or Steam Sterilization


[07613327589207]

Moist Heat or Steam Sterilization


[07613327589207]

Moist Heat or Steam Sterilization


[07613327589207]

Moist Heat or Steam Sterilization


[07613327589207]

Moist Heat or Steam Sterilization


[07613327589207]

Moist Heat or Steam Sterilization


[07613327589207]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-31
Device Publish Date2022-05-23

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