92-04005

GUDID 07613327503333

3D ORBITAL FLOOR PLATE, RIGHT, LARGE

Stryker Leibinger GmbH & Co. KG

Craniofacial fixation plate, non-bioabsorbable

Primary Device ID	07613327503333
NIH Device Record Key	42d3011e-fdca-43f0-bece-461bdd5e53d1
Commercial Distribution Status	In Commercial Distribution
Version Model Number	92-04005
Catalog Number	92-04005
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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327503333 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K133461

FDA Product Code

JEY	PLATE, BONE