56-25000

GUDID 34546540373985

Fixation Screws f. Condylar Prosthesis

Stryker Leibinger GmbH & Co. KG

Craniofacial bone screw, non-bioabsorbable, sterile
Primary Device ID34546540373985
NIH Device Record Key7b42c807-3645-4c27-81b0-f4054b89b2e9
Commercial Distribution StatusIn Commercial Distribution
Version Model Number56-25000
Catalog Number56-25000
Company DUNS316153956
Company NameStryker Leibinger GmbH & Co. KG
Device Count2
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

Length4.6 Millimeter
Length4.6 Millimeter
Length4.6 Millimeter
Length4.6 Millimeter
Device Size Text, specify0
Length4.6 Millimeter
Device Size Text, specify0
Length4.6 Millimeter
Device Size Text, specify0
Length4.6 Millimeter
Device Size Text, specify0
Length4.6 Millimeter
Device Size Text, specify0
Length4.6 Millimeter
Device Size Text, specify0
Length4.6 Millimeter
Device Size Text, specify0
Length4.6 Millimeter
Device Size Text, specify0
Length4.6 Millimeter
Device Size Text, specify0
Length4.6 Millimeter
Device Size Text, specify0
Length4.6 Millimeter
Device Size Text, specify0
Length4.6 Millimeter
Device Size Text, specify0
Length4.6 Millimeter
Device Size Text, specify0
Length4.6 Millimeter
Device Size Text, specify0
Length4.6 Millimeter
Device Size Text, specify0
Length4.6 Millimeter
Device Size Text, specify0
Length4.6 Millimeter
Device Size Text, specify0
Length4.6 Millimeter
Device Size Text, specify0
Length4.6 Millimeter
Device Size Text, specify0
Length4.6 Millimeter
Device Size Text, specify0
Length4.6 Millimeter
Device Size Text, specify0
Length4.6 Millimeter
Device Size Text, specify0
Length4.6 Millimeter
Device Size Text, specify0
Length4.6 Millimeter
Device Size Text, specify0
Length4.6 Millimeter
Device Size Text, specify0
Length4.6 Millimeter
Device Size Text, specify0
Length4.6 Millimeter
Device Size Text, specify0
Length4.6 Millimeter
Device Size Text, specify0
Length4.6 Millimeter
Device Size Text, specify0
Length4.6 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS104546540373984 [Unit of Use]
GS134546540373985 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MPLMandibular condyle prosthesis
NEIProsthesis, condyle, mandibular, temporary

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[34546540373985]

Moist Heat or Steam Sterilization


[34546540373985]

Moist Heat or Steam Sterilization


[34546540373985]

Moist Heat or Steam Sterilization


[34546540373985]

Moist Heat or Steam Sterilization


[34546540373985]

Moist Heat or Steam Sterilization


[34546540373985]

Moist Heat or Steam Sterilization


[34546540373985]

Moist Heat or Steam Sterilization


[34546540373985]

Moist Heat or Steam Sterilization


[34546540373985]

Moist Heat or Steam Sterilization


[34546540373985]

Moist Heat or Steam Sterilization


[34546540373985]

Moist Heat or Steam Sterilization


[34546540373985]

Moist Heat or Steam Sterilization


[34546540373985]

Moist Heat or Steam Sterilization


[34546540373985]

Moist Heat or Steam Sterilization


[34546540373985]

Moist Heat or Steam Sterilization


[34546540373985]

Moist Heat or Steam Sterilization


[34546540373985]

Moist Heat or Steam Sterilization


[34546540373985]

Moist Heat or Steam Sterilization


[34546540373985]

Moist Heat or Steam Sterilization


[34546540373985]

Moist Heat or Steam Sterilization


[34546540373985]

Moist Heat or Steam Sterilization


[34546540373985]

Moist Heat or Steam Sterilization


[34546540373985]

Moist Heat or Steam Sterilization


[34546540373985]

Moist Heat or Steam Sterilization


[34546540373985]

Moist Heat or Steam Sterilization


[34546540373985]

Moist Heat or Steam Sterilization


[34546540373985]

Moist Heat or Steam Sterilization


[34546540373985]

Moist Heat or Steam Sterilization


[34546540373985]

Moist Heat or Steam Sterilization


[34546540373985]

Moist Heat or Steam Sterilization


[34546540373985]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-07-01
Device Publish Date2015-09-24

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