78-91001

GUDID 07613327370706

FACIAL ID-RECON-1PLATE

Stryker Leibinger GmbH & Co. KG

Craniofacial fixation plate, non-bioabsorbable

Primary Device ID	07613327370706
NIH Device Record Key	6a1e0cdc-d60b-492c-93ab-870c0a37cca6
Commercial Distribution Status	In Commercial Distribution
Version Model Number	78-91001
Catalog Number	78-91001
Company DUNS	316153956
Company Name	Stryker Leibinger GmbH & Co. KG
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327370706 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K182305

FDA Product Code

JEY	PLATE, BONE

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

[07613327370706]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2019-03-04
Device Publish Date	2019-01-31

Devices Manufactured by Stryker Leibinger GmbH & Co. KG

07613252196259 - FLUOROMAP	2025-02-05 FLUOROMAP 1.0 - SALES DEMO CD
07613252286578 - FLUOROMAP	2025-02-05 FLUOROMAP 1.0 SOFTWARE
07613252286622 - FLUOROMAP	2025-02-05 FLUOROMAP 1.0 - ENABLE
07613327401523 - NA	2025-01-17 SternalPlate, Transverse, w/ bars
07613327401554 - NA	2025-01-17 SternalPlate, T
07613327401561 - NA	2025-01-17 SternalPlate, Transverse, w/ bars
07613327401738 - NA	2025-01-17 SternalPlate, T
07613327634952 - NA	2024-12-16 Drill for 6514-7-200 WL 16mm

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