56-25001

GUDID 04546540373991

TEMPORARY CONDYLAR PROSTHESIS, LEFT

Stryker Leibinger GmbH & Co. KG

Craniofacial fixation plate, non-bioabsorbable
Primary Device ID04546540373991
NIH Device Record Keya215c31c-4e69-4dd9-b73b-98ef8b114c34
Commercial Distribution StatusIn Commercial Distribution
Version Model Number56-25001
Catalog Number56-25001
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

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Device Identifiers

Device Issuing AgencyDevice ID
GS104546540373991 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NEIProsthesis, condyle, mandibular, temporary

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04546540373991]

Moist Heat or Steam Sterilization


[04546540373991]

Moist Heat or Steam Sterilization


[04546540373991]

Moist Heat or Steam Sterilization


[04546540373991]

Moist Heat or Steam Sterilization


[04546540373991]

Moist Heat or Steam Sterilization


[04546540373991]

Moist Heat or Steam Sterilization


[04546540373991]

Moist Heat or Steam Sterilization


[04546540373991]

Moist Heat or Steam Sterilization


[04546540373991]

Moist Heat or Steam Sterilization


[04546540373991]

Moist Heat or Steam Sterilization


[04546540373991]

Moist Heat or Steam Sterilization


[04546540373991]

Moist Heat or Steam Sterilization


[04546540373991]

Moist Heat or Steam Sterilization


[04546540373991]

Moist Heat or Steam Sterilization


[04546540373991]

Moist Heat or Steam Sterilization


[04546540373991]

Moist Heat or Steam Sterilization


[04546540373991]

Moist Heat or Steam Sterilization


[04546540373991]

Moist Heat or Steam Sterilization


[04546540373991]

Moist Heat or Steam Sterilization


[04546540373991]

Moist Heat or Steam Sterilization


[04546540373991]

Moist Heat or Steam Sterilization


[04546540373991]

Moist Heat or Steam Sterilization


[04546540373991]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-24

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