62-02335

GUDID 07613327294378

PMD 2, DEACTIVATION INSTRUMENT

Stryker Leibinger GmbH & Co. KG

Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 07613327294378
• NIH Device Record Key: 57c696cf-b259-4095-9009-05e18c121432
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 62-02335
• Catalog Number: 62-02335
• 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: 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: 110 Millimeter
• Device Size Text, specify: 0
• Length: 110 Millimeter
• Device Size Text, specify: 0
• Length: 110 Millimeter
• Device Size Text, specify: 0
• Length: 110 Millimeter
• Device Size Text, specify: 0
• Length: 110 Millimeter
• Device Size Text, specify: 0
• Length: 110 Millimeter
• Device Size Text, specify: 0
• Length: 110 Millimeter
• Device Size Text, specify: 0
• Length: 110 Millimeter
• Device Size Text, specify: 0
• Length: 110 Millimeter
• Device Size Text, specify: 0
• Length: 110 Millimeter
• Device Size Text, specify: 0
• Length: 110 Millimeter
• Device Size Text, specify: 0
• Length: 110 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327294378 [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

[07613327294378]

Moist Heat or Steam Sterilization

[07613327294378]

Moist Heat or Steam Sterilization

[07613327294378]

Moist Heat or Steam Sterilization

[07613327294378]

Moist Heat or Steam Sterilization

[07613327294378]

Moist Heat or Steam Sterilization

[07613327294378]

Moist Heat or Steam Sterilization

[07613327294378]

Moist Heat or Steam Sterilization

[07613327294378]

Moist Heat or Steam Sterilization

[07613327294378]

Moist Heat or Steam Sterilization

[07613327294378]

Moist Heat or Steam Sterilization

[07613327294378]

Moist Heat or Steam Sterilization

[07613327294378]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-22
• Device Publish Date: 2018-09-20

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