78-94004

GUDID 07613327556346

Facial iD MF 4 meshes

Stryker Leibinger GmbH & Co. KG

Craniofacial fixation plate, non-bioabsorbable, non-customized
Primary Device ID07613327556346
NIH Device Record Keye6a1d6aa-6867-4c5e-9b38-4b7c524c40f2
Commercial Distribution StatusIn Commercial Distribution
Version Model Number78-94004
Catalog Number78-94004
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 Identifiers

Device Issuing AgencyDevice ID
GS107613327556346 [Primary]

FDA Product Code

JEYPLATE, BONE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07613327556346]

Moist Heat or Steam Sterilization


[07613327556346]

Moist Heat or Steam Sterilization


[07613327556346]

Moist Heat or Steam Sterilization


[07613327556346]

Moist Heat or Steam Sterilization


[07613327556346]

Moist Heat or Steam Sterilization


[07613327556346]

Moist Heat or Steam Sterilization


[07613327556346]

Moist Heat or Steam Sterilization


[07613327556346]

Moist Heat or Steam Sterilization


[07613327556346]

Moist Heat or Steam Sterilization


[07613327556346]

Moist Heat or Steam Sterilization


[07613327556346]

Moist Heat or Steam Sterilization


[07613327556346]

Moist Heat or Steam Sterilization


[07613327556346]

Moist Heat or Steam Sterilization


[07613327556346]

Moist Heat or Steam Sterilization


[07613327556346]

Moist Heat or Steam Sterilization


[07613327556346]

Moist Heat or Steam Sterilization


[07613327556346]

Moist Heat or Steam Sterilization


[07613327556346]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-23
Device Publish Date2024-02-15

Devices Manufactured by Stryker Leibinger GmbH & Co. KG

07613252196259 - FLUOROMAP2025-02-05 FLUOROMAP 1.0 - SALES DEMO CD
07613252286578 - FLUOROMAP2025-02-05 FLUOROMAP 1.0 SOFTWARE
07613252286622 - FLUOROMAP2025-02-05 FLUOROMAP 1.0 - ENABLE
07613327401523 - NA2025-01-17 SternalPlate, Transverse, w/ bars
07613327401554 - NA2025-01-17 SternalPlate, T
07613327401561 - NA2025-01-17 SternalPlate, Transverse, w/ bars
07613327401738 - NA2025-01-17 SternalPlate, T
07613327634952 - NA2024-12-16 Drill for 6514-7-200 WL 16mm

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.