UNIVERSAL 2 92-15521

GUDID 07613327559316

MINI PLATE

Stryker Leibinger GmbH & Co. KG

Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable
Primary Device ID07613327559316
NIH Device Record Keye248267a-e4a6-457f-9967-70b7e5859076
Commercial Distribution StatusIn Commercial Distribution
Brand NameUNIVERSAL 2
Version Model Number92-15521
Catalog Number92-15521
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

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Device Identifiers

Device Issuing AgencyDevice ID
GS107613327559316 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JEYPLATE, BONE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07613327559316]

Moist Heat or Steam Sterilization


[07613327559316]

Moist Heat or Steam Sterilization


[07613327559316]

Moist Heat or Steam Sterilization


[07613327559316]

Moist Heat or Steam Sterilization


[07613327559316]

Moist Heat or Steam Sterilization


[07613327559316]

Moist Heat or Steam Sterilization


[07613327559316]

Moist Heat or Steam Sterilization


[07613327559316]

Moist Heat or Steam Sterilization


[07613327559316]

Moist Heat or Steam Sterilization


[07613327559316]

Moist Heat or Steam Sterilization


[07613327559316]

Moist Heat or Steam Sterilization


[07613327559316]

Moist Heat or Steam Sterilization


[07613327559316]

Moist Heat or Steam Sterilization


[07613327559316]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-04
Device Publish Date2021-04-26

On-Brand Devices [UNIVERSAL 2]

07613327559316MINI PLATE
07613327559293MINI PLATE

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