56-90326

GUDID 07613327123005

1,2MM DYNAMIC MESH-MALL-LARGE

Stryker Leibinger GmbH & Co. KG

Craniofacial fixation plate, non-bioabsorbable

Primary Device ID	07613327123005
NIH Device Record Key	475f8a55-82a4-4d20-bc21-3a7926c997f8
Commercial Distribution Status	In Commercial Distribution
Version Model Number	56-90326
Catalog Number	56-90326
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

Width	120 Millimeter
Device Size Text, specify	0
Length	120 Millimeter
Width	120 Millimeter
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Length	120 Millimeter
Width	120 Millimeter
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Length	120 Millimeter
Width	120 Millimeter
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Length	120 Millimeter
Width	120 Millimeter
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Length	120 Millimeter
Width	120 Millimeter
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Length	120 Millimeter
Width	120 Millimeter
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Length	120 Millimeter
Width	120 Millimeter
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Length	120 Millimeter
Width	120 Millimeter
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Length	120 Millimeter
Width	120 Millimeter
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Length	120 Millimeter
Width	120 Millimeter
Device Size Text, specify	0
Length	120 Millimeter
Width	120 Millimeter
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Length	120 Millimeter
Width	120 Millimeter
Device Size Text, specify	0
Length	120 Millimeter
Width	120 Millimeter
Device Size Text, specify	0
Length	120 Millimeter
Width	120 Millimeter
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Length	120 Millimeter
Width	120 Millimeter
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Length	120 Millimeter
Width	120 Millimeter
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Length	120 Millimeter
Width	120 Millimeter
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Length	120 Millimeter
Width	120 Millimeter
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Length	120 Millimeter
Width	120 Millimeter
Device Size Text, specify	0
Length	120 Millimeter
Width	120 Millimeter
Device Size Text, specify	0
Length	120 Millimeter
Width	120 Millimeter
Device Size Text, specify	0
Length	120 Millimeter
Width	120 Millimeter
Device Size Text, specify	0
Length	120 Millimeter
Width	120 Millimeter
Device Size Text, specify	0
Length	120 Millimeter
Width	120 Millimeter
Device Size Text, specify	0
Length	120 Millimeter
Width	120 Millimeter
Device Size Text, specify	0
Length	120 Millimeter
Width	120 Millimeter
Device Size Text, specify	0
Length	120 Millimeter
Width	120 Millimeter
Device Size Text, specify	0
Length	120 Millimeter
Width	120 Millimeter
Device Size Text, specify	0
Length	120 Millimeter
Width	120 Millimeter
Device Size Text, specify	0
Length	120 Millimeter
Width	120 Millimeter
Device Size Text, specify	0
Length	120 Millimeter
Width	120 Millimeter
Device Size Text, specify	0
Length	120 Millimeter
Width	120 Millimeter
Device Size Text, specify	0
Length	120 Millimeter
Width	120 Millimeter
Device Size Text, specify	0
Length	120 Millimeter
Width	120 Millimeter
Device Size Text, specify	0
Length	120 Millimeter
Width	120 Millimeter
Device Size Text, specify	0
Length	120 Millimeter
Width	120 Millimeter
Device Size Text, specify	0
Length	120 Millimeter
Width	120 Millimeter
Device Size Text, specify	0
Length	120 Millimeter
Width	120 Millimeter
Device Size Text, specify	0
Length	120 Millimeter
Width	120 Millimeter
Device Size Text, specify	0
Length	120 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327123005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K161821

FDA Product Code

GWO	Plate, cranioplasty, preformed, alterable