56-90628

GUDID 07613327123128

1,2MM DYNAMIC MESH-STD-X-LARGE

Stryker Leibinger GmbH & Co. KG

Craniofacial fixation plate, non-bioabsorbable

Primary Device ID	07613327123128
NIH Device Record Key	38c3c02d-3b8e-4bd2-b2ea-12e58a184155
Commercial Distribution Status	In Commercial Distribution
Version Model Number	56-90628
Catalog Number	56-90628
Company DUNS	316153956
Company Name	Stryker Leibinger GmbH & Co. KG
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Conditional
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	200 Millimeter
Width	200 Millimeter
Device Size Text, specify	0
Length	200 Millimeter
Width	200 Millimeter
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Length	200 Millimeter
Width	200 Millimeter
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Length	200 Millimeter
Width	200 Millimeter
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Length	200 Millimeter
Width	200 Millimeter
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Length	200 Millimeter
Width	200 Millimeter
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Length	200 Millimeter
Width	200 Millimeter
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Length	200 Millimeter
Width	200 Millimeter
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Length	200 Millimeter
Width	200 Millimeter
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Length	200 Millimeter
Width	200 Millimeter
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Length	200 Millimeter
Width	200 Millimeter
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Length	200 Millimeter
Width	200 Millimeter
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Length	200 Millimeter
Width	200 Millimeter
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Length	200 Millimeter
Width	200 Millimeter
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Length	200 Millimeter
Width	200 Millimeter
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Length	200 Millimeter
Width	200 Millimeter
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Length	200 Millimeter
Width	200 Millimeter
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Length	200 Millimeter
Width	200 Millimeter
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Length	200 Millimeter
Width	200 Millimeter
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Length	200 Millimeter
Width	200 Millimeter
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Length	200 Millimeter
Width	200 Millimeter
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Length	200 Millimeter
Width	200 Millimeter
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Length	200 Millimeter
Width	200 Millimeter
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Length	200 Millimeter
Width	200 Millimeter
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Length	200 Millimeter
Width	200 Millimeter
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Length	200 Millimeter
Width	200 Millimeter
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Length	200 Millimeter
Width	200 Millimeter
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Length	200 Millimeter
Width	200 Millimeter
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Length	200 Millimeter
Width	200 Millimeter
Device Size Text, specify	0
Length	200 Millimeter
Width	200 Millimeter
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Length	200 Millimeter
Width	200 Millimeter
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Length	200 Millimeter
Width	200 Millimeter
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Length	200 Millimeter
Width	200 Millimeter
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Length	200 Millimeter
Width	200 Millimeter
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Length	200 Millimeter
Width	200 Millimeter
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Length	200 Millimeter
Width	200 Millimeter
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Length	200 Millimeter
Width	200 Millimeter
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Length	200 Millimeter
Width	200 Millimeter
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Length	200 Millimeter
Width	200 Millimeter
Device Size Text, specify	0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327123128 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K161821

FDA Product Code

GWO	Plate, cranioplasty, preformed, alterable