56-90624

GUDID 07613327123104

1,2MM DYNAMIC MESH-STD-MEDIUM

Stryker Leibinger GmbH & Co. KG

Craniofacial fixation plate, non-bioabsorbable
Primary Device ID07613327123104
NIH Device Record Keyb0d3e4db-95c7-4554-9e84-10b750415e6d
Commercial Distribution StatusIn Commercial Distribution
Version Model Number56-90624
Catalog Number56-90624
Company DUNS316153956
Company NameStryker Leibinger GmbH & Co. KG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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

Length90 Millimeter
Width90 Millimeter
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Device Identifiers

Device Issuing AgencyDevice ID
GS107613327123104 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWOPlate, cranioplasty, preformed, alterable

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


[07613327123104]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-03-31

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