78-21020

GUDID 07613252578239

CUSTOMIZED MAND. RECON PLATE20 KIT, FULL

Stryker Leibinger GmbH & Co. KG

Craniofacial fixation plate kit, non-bioabsorbable

Primary Device ID	07613252578239
NIH Device Record Key	d2b00644-5f94-4d1f-83cd-c773d584dd67
Commercial Distribution Status	In Commercial Distribution
Version Model Number	78-21020
Catalog Number	78-21020
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	07613252578239 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K132519

FDA Product Code

JEY	PLATE, BONE

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

[07613252578239]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2015-07-03

Devices Manufactured by Stryker Leibinger GmbH & Co. KG

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07613327504392 - NA	2025-03-06 PEDIATRIC MANDIBULAR DISTRACTOR 2
07613327353563 - NA	2025-02-27 NAVIGATED DRILL GUIDE SET CONTAINER
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

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