92-10061

GUDID 07613327520293

ACTIVATION HANDLE

Stryker Leibinger GmbH & Co. KG

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 07613327520293
• NIH Device Record Key: ef2ab33f-accc-4090-b265-e73f5c1bc9d4
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 92-10061
• Catalog Number: 92-10061
• 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: false
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Length: 125 Millimeter
• Device Size Text, specify: 0
• Length: 125 Millimeter
• Device Size Text, specify: 0
• Length: 125 Millimeter
• Device Size Text, specify: 0
• Length: 125 Millimeter
• Device Size Text, specify: 0
• Length: 125 Millimeter
• Device Size Text, specify: 0
• Length: 125 Millimeter
• Device Size Text, specify: 0
• Length: 125 Millimeter
• Device Size Text, specify: 0
• Length: 125 Millimeter
• Device Size Text, specify: 0
• Length: 125 Millimeter
• Device Size Text, specify: 0
• Length: 125 Millimeter
• Device Size Text, specify: 0
• Length: 125 Millimeter
• Device Size Text, specify: 0
• Length: 125 Millimeter
• Device Size Text, specify: 0
• Length: 125 Millimeter
• Device Size Text, specify: 0
• Length: 125 Millimeter
• Device Size Text, specify: 0
• Length: 125 Millimeter
• Device Size Text, specify: 0
• Length: 125 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327520293 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181504

FDA Product Code

• MQN: EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR

Sterilization

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

[07613327520293]

Moist Heat or Steam Sterilization

[07613327520293]

Moist Heat or Steam Sterilization

[07613327520293]

Moist Heat or Steam Sterilization

[07613327520293]

Moist Heat or Steam Sterilization

[07613327520293]

Moist Heat or Steam Sterilization

[07613327520293]

Moist Heat or Steam Sterilization

[07613327520293]

Moist Heat or Steam Sterilization

[07613327520293]

Moist Heat or Steam Sterilization

[07613327520293]

Moist Heat or Steam Sterilization

[07613327520293]

Moist Heat or Steam Sterilization

[07613327520293]

Moist Heat or Steam Sterilization

[07613327520293]

Moist Heat or Steam Sterilization

[07613327520293]

Moist Heat or Steam Sterilization

[07613327520293]

Moist Heat or Steam Sterilization

[07613327520293]

Moist Heat or Steam Sterilization

[07613327520293]

Moist Heat or Steam Sterilization

[07613327520293]

Moist Heat or Steam Sterilization

[07613327520293]

Moist Heat or Steam Sterilization

[07613327520293]

Moist Heat or Steam Sterilization

[07613327520293]

Moist Heat or Steam Sterilization

[07613327520293]

Moist Heat or Steam Sterilization

[07613327520293]

Moist Heat or Steam Sterilization

[07613327520293]

Moist Heat or Steam Sterilization

[07613327520293]

Moist Heat or Steam Sterilization

[07613327520293]

Moist Heat or Steam Sterilization

[07613327520293]

Moist Heat or Steam Sterilization

[07613327520293]

Moist Heat or Steam Sterilization

[07613327520293]

Moist Heat or Steam Sterilization

[07613327520293]

Moist Heat or Steam Sterilization

[07613327520293]

Moist Heat or Steam Sterilization

[07613327520293]

Moist Heat or Steam Sterilization

[07613327520293]

Moist Heat or Steam Sterilization

[07613327520293]

Moist Heat or Steam Sterilization

[07613327520293]

Moist Heat or Steam Sterilization

[07613327520293]

Moist Heat or Steam Sterilization

[07613327520293]

Moist Heat or Steam Sterilization

[07613327520293]

Moist Heat or Steam Sterilization

[07613327520293]

Moist Heat or Steam Sterilization

[07613327520293]

Moist Heat or Steam Sterilization

[07613327520293]

Moist Heat or Steam Sterilization

[07613327520293]

Moist Heat or Steam Sterilization

[07613327520293]

Moist Heat or Steam Sterilization

[07613327520293]

Moist Heat or Steam Sterilization

[07613327520293]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-11-03
• Device Publish Date: 2020-10-26

Devices Manufactured by Stryker Leibinger GmbH & Co. KG

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• 07613327401554 - NA: 2025-01-17 SternalPlate, T
• 07613327401561 - NA: 2025-01-17 SternalPlate, Transverse, w/ bars
• 07613327401738 - NA: 2025-01-17 SternalPlate, T
• 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