54-04005

GUDID 07613252524151

3D ORBITAL FLOOR PLATE, RIGHT, LARGE

Stryker Leibinger GmbH & Co. KG

Craniofacial fixation plate, non-bioabsorbable

Primary Device ID	07613252524151
NIH Device Record Key	04afc3e9-953f-4437-954b-5a66819cfb27
Commercial Distribution Status	In Commercial Distribution
Version Model Number	54-04005
Catalog Number	54-04005
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 Dimensions

Height	16 Millimeter
Device Size Text, specify	0
Width	36 Millimeter
Length	35 Millimeter
Height	16 Millimeter
Device Size Text, specify	0
Width	36 Millimeter
Length	35 Millimeter
Height	16 Millimeter
Device Size Text, specify	0
Width	36 Millimeter
Length	35 Millimeter
Height	16 Millimeter
Device Size Text, specify	0
Width	36 Millimeter
Length	35 Millimeter
Height	16 Millimeter
Device Size Text, specify	0
Width	36 Millimeter
Length	35 Millimeter
Height	16 Millimeter
Device Size Text, specify	0
Width	36 Millimeter
Length	35 Millimeter
Height	16 Millimeter
Device Size Text, specify	0
Width	36 Millimeter
Length	35 Millimeter
Height	16 Millimeter
Device Size Text, specify	0
Width	36 Millimeter
Length	35 Millimeter
Height	16 Millimeter
Device Size Text, specify	0
Width	36 Millimeter
Length	35 Millimeter
Height	16 Millimeter
Device Size Text, specify	0
Width	36 Millimeter
Length	35 Millimeter
Height	16 Millimeter
Device Size Text, specify	0
Width	36 Millimeter
Length	35 Millimeter
Height	16 Millimeter
Device Size Text, specify	0
Width	36 Millimeter
Length	35 Millimeter
Height	16 Millimeter
Device Size Text, specify	0
Width	36 Millimeter
Length	35 Millimeter
Height	16 Millimeter
Device Size Text, specify	0
Width	36 Millimeter
Length	35 Millimeter
Height	16 Millimeter
Device Size Text, specify	0
Width	36 Millimeter
Length	35 Millimeter
Height	16 Millimeter
Device Size Text, specify	0
Width	36 Millimeter
Length	35 Millimeter
Height	16 Millimeter
Device Size Text, specify	0
Width	36 Millimeter
Length	35 Millimeter
Height	16 Millimeter
Device Size Text, specify	0
Width	36 Millimeter
Length	35 Millimeter
Height	16 Millimeter
Device Size Text, specify	0
Width	36 Millimeter
Length	35 Millimeter
Height	16 Millimeter
Device Size Text, specify	0
Width	36 Millimeter
Length	35 Millimeter
Height	16 Millimeter
Device Size Text, specify	0
Width	36 Millimeter
Length	35 Millimeter
Height	16 Millimeter
Device Size Text, specify	0
Width	36 Millimeter
Length	35 Millimeter
Height	16 Millimeter
Device Size Text, specify	0
Width	36 Millimeter
Length	35 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613252524151 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K123786

FDA Product Code

JEY	PLATE, BONE