92-04004

GUDID 07613327503357

3D ORBITAL FLOOR PLATE, RIGHT, SMALL

Stryker Leibinger GmbH & Co. KG

Craniofacial fixation plate, non-bioabsorbable

Primary Device ID	07613327503357
NIH Device Record Key	b46c9edf-e8fa-4e5f-a714-a5f60bf5b8e2
Commercial Distribution Status	In Commercial Distribution
Version Model Number	92-04004
Catalog Number	92-04004
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

Width	34 Millimeter
Height	12 Millimeter
Device Size Text, specify	0
Length	31 Millimeter
Width	34 Millimeter
Height	12 Millimeter
Device Size Text, specify	0
Length	31 Millimeter
Width	34 Millimeter
Height	12 Millimeter
Device Size Text, specify	0
Length	31 Millimeter
Width	34 Millimeter
Height	12 Millimeter
Device Size Text, specify	0
Length	31 Millimeter
Width	34 Millimeter
Height	12 Millimeter
Device Size Text, specify	0
Length	31 Millimeter
Width	34 Millimeter
Height	12 Millimeter
Device Size Text, specify	0
Length	31 Millimeter
Width	34 Millimeter
Height	12 Millimeter
Device Size Text, specify	0
Length	31 Millimeter
Width	34 Millimeter
Height	12 Millimeter
Device Size Text, specify	0
Length	31 Millimeter
Width	34 Millimeter
Height	12 Millimeter
Device Size Text, specify	0
Length	31 Millimeter
Width	34 Millimeter
Height	12 Millimeter
Device Size Text, specify	0
Length	31 Millimeter
Width	34 Millimeter
Height	12 Millimeter
Device Size Text, specify	0
Length	31 Millimeter
Width	34 Millimeter
Height	12 Millimeter
Device Size Text, specify	0
Length	31 Millimeter
Width	34 Millimeter
Height	12 Millimeter
Device Size Text, specify	0
Length	31 Millimeter
Width	34 Millimeter
Height	12 Millimeter
Device Size Text, specify	0
Length	31 Millimeter
Width	34 Millimeter
Height	12 Millimeter
Device Size Text, specify	0
Length	31 Millimeter
Width	34 Millimeter
Height	12 Millimeter
Device Size Text, specify	0
Length	31 Millimeter
Width	34 Millimeter
Height	12 Millimeter
Device Size Text, specify	0
Length	31 Millimeter
Width	34 Millimeter
Height	12 Millimeter
Device Size Text, specify	0
Length	31 Millimeter
Width	34 Millimeter
Height	12 Millimeter
Device Size Text, specify	0
Length	31 Millimeter
Width	34 Millimeter
Height	12 Millimeter
Device Size Text, specify	0
Length	31 Millimeter
Width	34 Millimeter
Height	12 Millimeter
Device Size Text, specify	0
Length	31 Millimeter
Width	34 Millimeter
Height	12 Millimeter
Device Size Text, specify	0
Length	31 Millimeter
Width	34 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327503357 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K133461

FDA Product Code

JEY	PLATE, BONE