92-10543

GUDID 07613327589207

3-D PLATE, OBLIQUE

Stryker Leibinger GmbH & Co. KG

Craniofacial fixation plate, non-bioabsorbable

• Primary Device ID: 07613327589207
• NIH Device Record Key: 03f944e1-8767-464c-9c61-4644c8f37203
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 92-10543
• Catalog Number: 92-10543
• Company DUNS: 316153956
• Company Name: Stryker Leibinger GmbH & Co. KG
• Device Count: 1
• 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: 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

• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327589207 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K014263

FDA Product Code

• JEY: PLATE, BONE

Sterilization

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

[07613327589207]

Moist Heat or Steam Sterilization

[07613327589207]

Moist Heat or Steam Sterilization

[07613327589207]

Moist Heat or Steam Sterilization

[07613327589207]

Moist Heat or Steam Sterilization

[07613327589207]

Moist Heat or Steam Sterilization

[07613327589207]

Moist Heat or Steam Sterilization

[07613327589207]

Moist Heat or Steam Sterilization

[07613327589207]

Moist Heat or Steam Sterilization

[07613327589207]

Moist Heat or Steam Sterilization

[07613327589207]

Moist Heat or Steam Sterilization

[07613327589207]

Moist Heat or Steam Sterilization

[07613327589207]

Moist Heat or Steam Sterilization

[07613327589207]

Moist Heat or Steam Sterilization

[07613327589207]

Moist Heat or Steam Sterilization

[07613327589207]

Moist Heat or Steam Sterilization

[07613327589207]

Moist Heat or Steam Sterilization

[07613327589207]

Moist Heat or Steam Sterilization

[07613327589207]

Moist Heat or Steam Sterilization

[07613327589207]

Moist Heat or Steam Sterilization

[07613327589207]

Moist Heat or Steam Sterilization

[07613327589207]

Moist Heat or Steam Sterilization

[07613327589207]

Moist Heat or Steam Sterilization

[07613327589207]

Moist Heat or Steam Sterilization

[07613327589207]

Moist Heat or Steam Sterilization

[07613327589207]

Moist Heat or Steam Sterilization

[07613327589207]

Moist Heat or Steam Sterilization

[07613327589207]

Moist Heat or Steam Sterilization

[07613327589207]

Moist Heat or Steam Sterilization

[07613327589207]

Moist Heat or Steam Sterilization

[07613327589207]

Moist Heat or Steam Sterilization

[07613327589207]

Moist Heat or Steam Sterilization

[07613327589207]

Moist Heat or Steam Sterilization

[07613327589207]

Moist Heat or Steam Sterilization

[07613327589207]

Moist Heat or Steam Sterilization

[07613327589207]

Moist Heat or Steam Sterilization

[07613327589207]

Moist Heat or Steam Sterilization

[07613327589207]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-31
• Device Publish Date: 2022-05-23

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