78-30020

GUDID 07613252599647

CUSTOMIZED MAND. RECON PLATE20, HEMI

Stryker Leibinger GmbH & Co. KG

Craniofacial fixation plate, non-bioabsorbable

Primary Device ID	07613252599647
NIH Device Record Key	a290014c-e237-4c9b-a18e-30ecdde95ed0
Commercial Distribution Status	In Commercial Distribution
Version Model Number	78-30020
Catalog Number	78-30020
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	07613252599647 [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

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

Moist Heat or Steam Sterilization

[07613252599647]

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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07613327616286 - N/A	2024-08-23 Spine Guidance 5 Sales Demo
07613327638189 - N/A	2024-08-23 Spine Guidance 5 Upgrade
07613327638196 - N/A	2024-08-23 Spine Guidance 5 Update
07613327579833 - N/A	2024-08-15 Tracker-70
07613327579888 - N/A	2024-08-15 Tracking Instrument Battery
07613327635102 - NA	2024-07-18 Neuro Dynamic Mesh L

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