56-90814S

GUDID 07613327382525

1.5/1.7MM DYNAMIC MESH-STIFF-MEDIUM-S

Stryker Leibinger GmbH & Co. KG

Craniofacial fixation plate, non-bioabsorbable

Primary Device ID	07613327382525
NIH Device Record Key	38f2da90-466b-4f28-9cb3-7291e9bd3182
Commercial Distribution Status	In Commercial Distribution
Version Model Number	56-90814S
Catalog Number	56-90814S
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	false
Expiration Date	true
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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Length	90 Millimeter
Width	90 Millimeter
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Width	90 Millimeter
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Length	90 Millimeter
Width	90 Millimeter
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Length	90 Millimeter
Width	90 Millimeter
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Length	90 Millimeter
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Length	90 Millimeter
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Width	90 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327382525 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K182425

FDA Product Code

GWO	Plate, cranioplasty, preformed, alterable

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2018-12-20
Device Publish Date	2018-11-19

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