390024

GUDID 37613327072717

Wire with Eye

Stryker Trauma SA

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Primary Device ID	37613327072717
NIH Device Record Key	3c95abd6-cb64-4204-aca0-05c2ceb21eec
Commercial Distribution Status	In Commercial Distribution
Version Model Number	390024
Catalog Number	390024
Company DUNS	481999654
Company Name	Stryker Trauma SA
Device Count	10
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	false
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	500 Millimeter
Device Size Text, specify	0
Length	500 Millimeter
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Length	500 Millimeter
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Length	500 Millimeter
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Length	500 Millimeter
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Length	500 Millimeter
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Length	500 Millimeter
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Length	500 Millimeter
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Length	500 Millimeter
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Length	500 Millimeter
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Length	500 Millimeter
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Length	500 Millimeter
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Length	500 Millimeter
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Length	500 Millimeter
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Length	500 Millimeter
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Length	500 Millimeter
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Length	500 Millimeter
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Length	500 Millimeter
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Length	500 Millimeter
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Length	500 Millimeter
Device Size Text, specify	0
Length	500 Millimeter
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Length	500 Millimeter
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Length	500 Millimeter
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Length	500 Millimeter
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Length	500 Millimeter
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Length	500 Millimeter
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Length	500 Millimeter
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Length	500 Millimeter
Device Size Text, specify	0
Length	500 Millimeter
Device Size Text, specify	0
Length	500 Millimeter
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Length	500 Millimeter
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Length	500 Millimeter
Device Size Text, specify	0
Length	500 Millimeter
Device Size Text, specify	0
Length	500 Millimeter
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Length	500 Millimeter
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Length	500 Millimeter
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Length	500 Millimeter
Device Size Text, specify	0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327072716 [Unit of Use]
GS1	37613327072717 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K914374

FDA Product Code

JDQ	CERCLAGE, FIXATION