62-20020

GUDID 34546540259043

SELF-DRILLING PINS, AUTO PILOT

Stryker Leibinger GmbH & Co. KG

Orthopaedic bone pin, non-bioabsorbable

• Primary Device ID: 34546540259043
• NIH Device Record Key: 6573fa2e-7cb6-40fa-8368-d95df10c28ca
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 62-20020
• Catalog Number: 62-20020
• 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

• Length: 60 Millimeter
• Length: 60 Millimeter
• Length: 60 Millimeter
• Length: 60 Millimeter
• Length: 60 Millimeter
• Length: 60 Millimeter
• Length: 60 Millimeter
• Length: 60 Millimeter
• Length: 6 Centimeter
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Length: 6 Centimeter
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Length: 6 Centimeter
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Length: 6 Centimeter
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Length: 6 Centimeter
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Length: 6 Centimeter
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Length: 6 Centimeter
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Length: 6 Centimeter
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Length: 6 Centimeter
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Length: 6 Centimeter
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Length: 6 Centimeter
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Length: 6 Centimeter
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Length: 6 Centimeter
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540259042 [Unit of Use]
GS1	34546540259043 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K960297

FDA Product Code

• MQN: EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR

Sterilization

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

[34546540259043]

Moist Heat or Steam Sterilization

[34546540259043]

Moist Heat or Steam Sterilization

[34546540259043]

Moist Heat or Steam Sterilization

[34546540259043]

Moist Heat or Steam Sterilization

[34546540259043]

Moist Heat or Steam Sterilization

[34546540259043]

Moist Heat or Steam Sterilization

[34546540259043]

Moist Heat or Steam Sterilization

[34546540259043]

Moist Heat or Steam Sterilization

[34546540259043]

Moist Heat or Steam Sterilization

[34546540259043]

Moist Heat or Steam Sterilization

[34546540259043]

Moist Heat or Steam Sterilization

[34546540259043]

Moist Heat or Steam Sterilization

[34546540259043]

Moist Heat or Steam Sterilization

[34546540259043]

Moist Heat or Steam Sterilization

[34546540259043]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-07-01
• Device Publish Date: 2015-07-07

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• 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