Able Medical Devices 05-05-2528

GUDID 00810071391446

Temporary Fixation Pin

J.M. Longyear Manufacturing, LLC

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 00810071391446
• NIH Device Record Key: c5636d11-26c2-45cf-a1f4-50873b374c63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Able Medical Devices
• Version Model Number: 05-05-2528
• Catalog Number: 05-05-2528
• Company DUNS: 081307059
• Company Name: J.M. Longyear Manufacturing, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00810071391446 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00810071391446]

Moist Heat or Steam Sterilization

[00810071391446]

Moist Heat or Steam Sterilization

[00810071391446]

Moist Heat or Steam Sterilization

[00810071391446]

Moist Heat or Steam Sterilization

[00810071391446]

Moist Heat or Steam Sterilization

[00810071391446]

Moist Heat or Steam Sterilization

[00810071391446]

Moist Heat or Steam Sterilization

[00810071391446]

Moist Heat or Steam Sterilization

[00810071391446]

Moist Heat or Steam Sterilization

[00810071391446]

Moist Heat or Steam Sterilization

[00810071391446]

Moist Heat or Steam Sterilization

[00810071391446]

Moist Heat or Steam Sterilization

[00810071391446]

Moist Heat or Steam Sterilization

[00810071391446]

Moist Heat or Steam Sterilization

[00810071391446]

Moist Heat or Steam Sterilization

[00810071391446]

Moist Heat or Steam Sterilization

[00810071391446]

Moist Heat or Steam Sterilization

[00810071391446]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-26
• Device Publish Date: 2024-12-18

On-Brand Devices [Able Medical Devices]

• 00810071391453: Ball End Temporary Fixation Pin
• 00810071391446: Temporary Fixation Pin
• 00810071391439: Rib Plate Holder