Universal Mandible AXS 56-25003

GUDID 07613327572087

Condylar Prosthesis fixation screws, AXS

Stryker Leibinger GmbH & Co. KG

Craniofacial bone screw, non-bioabsorbable

• Primary Device ID: 07613327572087
• NIH Device Record Key: 31e924c0-8523-4441-a4b7-1ed6a13d1523
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Universal Mandible AXS
• Version Model Number: 56-25003
• Catalog Number: 56-25003
• Company DUNS: 316153956
• Company Name: Stryker Leibinger GmbH & Co. KG
• Device Count: 2
• 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

• Device Size Text, specify: 0
• Length: 4.6 Millimeter
• Device Size Text, specify: 0
• Length: 4.6 Millimeter
• Device Size Text, specify: 0
• Length: 4.6 Millimeter
• Device Size Text, specify: 0
• Length: 4.6 Millimeter
• Device Size Text, specify: 0
• Length: 4.6 Millimeter
• Device Size Text, specify: 0
• Length: 4.6 Millimeter
• Device Size Text, specify: 0
• Length: 4.6 Millimeter
• Device Size Text, specify: 0
• Length: 4.6 Millimeter
• Device Size Text, specify: 0
• Length: 4.6 Millimeter
• Device Size Text, specify: 0
• Length: 4.6 Millimeter
• Device Size Text, specify: 0
• Length: 4.6 Millimeter
• Device Size Text, specify: 0
• Length: 4.6 Millimeter
• Device Size Text, specify: 0
• Length: 4.6 Millimeter
• Device Size Text, specify: 0
• Length: 4.6 Millimeter
• Device Size Text, specify: 0
• Length: 4.6 Millimeter
• Device Size Text, specify: 0
• Length: 4.6 Millimeter
• Device Size Text, specify: 0
• Length: 4.6 Millimeter
• Device Size Text, specify: 0
• Length: 4.6 Millimeter
• Device Size Text, specify: 0
• Length: 4.6 Millimeter
• Device Size Text, specify: 0
• Length: 4.6 Millimeter
• Device Size Text, specify: 0
• Length: 4.6 Millimeter
• Device Size Text, specify: 0
• Length: 4.6 Millimeter
• Device Size Text, specify: 0
• Length: 4.6 Millimeter
• Device Size Text, specify: 0
• Length: 4.6 Millimeter
• Device Size Text, specify: 0
• Length: 4.6 Millimeter
• Device Size Text, specify: 0
• Length: 4.6 Millimeter
• Device Size Text, specify: 0
• Length: 4.6 Millimeter
• Device Size Text, specify: 0
• Length: 4.6 Millimeter
• Device Size Text, specify: 0
• Length: 4.6 Millimeter
• Device Size Text, specify: 0
• Length: 4.6 Millimeter
• Device Size Text, specify: 0
• Length: 4.6 Millimeter
• Device Size Text, specify: 0
• Length: 4.6 Millimeter
• Device Size Text, specify: 0
• Length: 4.6 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327572087 [Unit of Use]
GS1	37613327572088 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133285

FDA Product Code

• NEI: Prosthesis, condyle, mandibular, temporary

Sterilization

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

[07613327572087]

Moist Heat or Steam Sterilization

[07613327572087]

Moist Heat or Steam Sterilization

[07613327572087]

Moist Heat or Steam Sterilization

[07613327572087]

Moist Heat or Steam Sterilization

[07613327572087]

Moist Heat or Steam Sterilization

[07613327572087]

Moist Heat or Steam Sterilization

[07613327572087]

Moist Heat or Steam Sterilization

[07613327572087]

Moist Heat or Steam Sterilization

[07613327572087]

Moist Heat or Steam Sterilization

[07613327572087]

Moist Heat or Steam Sterilization

[07613327572087]

Moist Heat or Steam Sterilization

[07613327572087]

Moist Heat or Steam Sterilization

[07613327572087]

Moist Heat or Steam Sterilization

[07613327572087]

Moist Heat or Steam Sterilization

[07613327572087]

Moist Heat or Steam Sterilization

[07613327572087]

Moist Heat or Steam Sterilization

[07613327572087]

Moist Heat or Steam Sterilization

[07613327572087]

Moist Heat or Steam Sterilization

[07613327572087]

Moist Heat or Steam Sterilization

[07613327572087]

Moist Heat or Steam Sterilization

[07613327572087]

Moist Heat or Steam Sterilization

[07613327572087]

Moist Heat or Steam Sterilization

[07613327572087]

Moist Heat or Steam Sterilization

[07613327572087]

Moist Heat or Steam Sterilization

[07613327572087]

Moist Heat or Steam Sterilization

[07613327572087]

Moist Heat or Steam Sterilization

[07613327572087]

Moist Heat or Steam Sterilization

[07613327572087]

Moist Heat or Steam Sterilization

[07613327572087]

Moist Heat or Steam Sterilization

[07613327572087]

Moist Heat or Steam Sterilization

[07613327572087]

Moist Heat or Steam Sterilization

[07613327572087]

Moist Heat or Steam Sterilization

[07613327572087]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-25
• Device Publish Date: 2023-09-15

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