3715-3-040

GUDID 07613327094862

Trocar Point, both ends Kirschner Wire

Stryker Trauma SA

Bone nail guidewire, reusable

• Primary Device ID: 07613327094862
• NIH Device Record Key: 9ce3f0c1-b2e4-45e5-acfe-1a6f2b85eb0a
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 3715-3-040
• Catalog Number: 3715-3-040
• Company DUNS: 481999654
• Company Name: Stryker Trauma SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 100 Millimeter
• Device Size Text, specify: 0
• Length: 100 Millimeter
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Length: 100 Millimeter
• Device Size Text, specify: 0
• Length: 100 Millimeter
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Length: 100 Millimeter
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Length: 100 Millimeter
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Length: 100 Millimeter
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Length: 100 Millimeter
• Device Size Text, specify: 0
• Length: 100 Millimeter
• Device Size Text, specify: 0
• Length: 100 Millimeter
• Device Size Text, specify: 0
• Length: 100 Millimeter
• Device Size Text, specify: 0
• Length: 100 Millimeter
• Device Size Text, specify: 0
• Length: 100 Millimeter
• Device Size Text, specify: 0
• Length: 100 Millimeter
• Device Size Text, specify: 0
• Length: 100 Millimeter
• Device Size Text, specify: 0
• Length: 100 Millimeter
• Device Size Text, specify: 0
• Length: 100 Millimeter
• Device Size Text, specify: 0
• Length: 100 Millimeter
• Device Size Text, specify: 0
• Length: 100 Millimeter
• Device Size Text, specify: 0
• Length: 100 Millimeter
• Device Size Text, specify: 0
• Length: 100 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327094862 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211508

FDA Product Code

• HTY: PIN, FIXATION, SMOOTH
• JDW: Pin, Fixation, Threaded

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

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[07613327094862]

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[07613327094862]

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[07613327094862]

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[07613327094862]

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[07613327094862]

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[07613327094862]

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[07613327094862]

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[07613327094862]

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[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

[07613327094862]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-26
• Device Publish Date: 2020-02-18

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