UNIVERSAL NEURO 2, UNIVERSAL NEURO III 54-00346

GUDID 04546540237606

DYNAMIC MESH MALL. F. 1.5/1.7MM SCREWS

Stryker Leibinger GmbH & Co. KG

Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized

Primary Device ID	04546540237606
NIH Device Record Key	36ca7fa0-391f-4445-a426-6c76997d05cb
Commercial Distribution Status	In Commercial Distribution
Brand Name	UNIVERSAL NEURO 2, UNIVERSAL NEURO III
Version Model Number	54-00346
Catalog Number	54-00346
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

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Width	90 Millimeter
Length	90 Millimeter
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Width	90 Millimeter
Length	90 Millimeter
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Width	90 Millimeter
Length	90 Millimeter
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Width	90 Millimeter
Length	90 Millimeter
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Width	90 Millimeter
Length	90 Millimeter
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Width	90 Millimeter
Length	90 Millimeter
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Width	90 Millimeter
Length	90 Millimeter
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Width	90 Millimeter
Length	90 Millimeter
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Width	90 Millimeter
Length	90 Millimeter
Device Size Text, specify	0
Width	90 Millimeter
Length	90 Millimeter
Device Size Text, specify	0
Width	90 Millimeter
Length	90 Millimeter
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Width	90 Millimeter
Length	90 Millimeter
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Width	90 Millimeter
Length	90 Millimeter
Device Size Text, specify	0
Width	90 Millimeter
Length	90 Millimeter
Device Size Text, specify	0
Width	90 Millimeter
Length	90 Millimeter
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Width	90 Millimeter
Length	90 Millimeter
Device Size Text, specify	0
Width	90 Millimeter
Length	90 Millimeter
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Width	90 Millimeter
Length	90 Millimeter
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Width	90 Millimeter
Length	90 Millimeter
Device Size Text, specify	0
Width	90 Millimeter
Length	90 Millimeter
Device Size Text, specify	0
Width	90 Millimeter
Length	90 Millimeter
Device Size Text, specify	0
Width	90 Millimeter
Length	90 Millimeter
Device Size Text, specify	0
Width	90 Millimeter
Length	90 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540237606 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K983528

FDA Product Code

JEY	PLATE, BONE