UNIVERSAL NEURO 2, QUIKFLAP 50-15004

GUDID 37613154481744

NEURO SCREWS,CROSS-PIN,SELF-TAPPING

Stryker Leibinger GmbH & Co. KG

Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable

Primary Device ID	37613154481744
NIH Device Record Key	40c4f159-5027-4fa9-bfe5-705b3c359d84
Commercial Distribution Status	In Commercial Distribution
Brand Name	UNIVERSAL NEURO 2, QUIKFLAP
Version Model Number	50-15004
Catalog Number	50-15004
Company DUNS	316153956
Company Name	Stryker Leibinger GmbH & Co. KG
Device Count	5
DM Exempt	true
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

Device Size Text, specify	0
Length	4 Millimeter
Device Size Text, specify	0
Length	4 Millimeter
Device Size Text, specify	0
Length	4 Millimeter
Device Size Text, specify	0
Length	4 Millimeter
Device Size Text, specify	0
Length	4 Millimeter
Device Size Text, specify	0
Length	4 Millimeter
Device Size Text, specify	0
Length	4 Millimeter
Device Size Text, specify	0
Length	4 Millimeter
Device Size Text, specify	0
Length	4 Millimeter
Device Size Text, specify	0
Length	4 Millimeter
Device Size Text, specify	0
Length	4 Millimeter
Device Size Text, specify	0
Length	4 Millimeter
Device Size Text, specify	0
Length	4 Millimeter
Device Size Text, specify	0
Length	4 Millimeter
Device Size Text, specify	0
Length	4 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613154481743 [Unit of Use]
GS1	37613154481744 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K031659

FDA Product Code

JEY	PLATE, BONE