78-93107

GUDID 07613327371123

FACIAL ID-TRAUMA-7PLATES, KIT

Stryker Leibinger GmbH & Co. KG

Craniofacial fixation plate kit, non-bioabsorbable

• Primary Device ID: 07613327371123
• NIH Device Record Key: b88f7e8e-1a23-4907-b31d-8cf64a078acc
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 78-93107
• Catalog Number: 78-93107
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	07613327371123 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182305

FDA Product Code

• JEY: PLATE, BONE

Sterilization

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

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

[07613327371123]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-04
• Device Publish Date: 2019-01-31

Devices Manufactured by Stryker Leibinger GmbH & Co. KG

• 07613327634952 - NA: 2024-12-16 Drill for 6514-7-200 WL 16mm
• 07613327634969 - NA: 2024-12-16 Drill for 6514-7-200 WL 12mm
• 07613327634976 - NA: 2024-12-16 Drill for 6514-7-200 WL 10mm
• 07613327634983 - NA: 2024-12-16 Drill for 6514-7-200 WL 12mm
• 07613327634990 - NA: 2024-12-16 Drill for 6514-7-200 14mm
• 07613327635003 - NA: 2024-12-16 Drill for 6514-7-200 WL 10mm
• 07613327635010 - NA: 2024-12-16 Drill for 6514-7-200 WL 14mm
• 07613327651058 - NA: 2024-11-20 T-plate malleable left