Guide Pin - Bevel

GUDID 00810131880910

SURGENTEC, LLC

Orthopaedic bone pin, non-bioabsorbable

• Primary Device ID: 00810131880910
• NIH Device Record Key: 8551e2ac-102f-4bfe-b597-4ad3ca62c5c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guide Pin - Bevel
• Version Model Number: SR99-5006
• Company DUNS: 004095409
• Company Name: SURGENTEC, 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: 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	00810131880910 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00810131880910]

Moist Heat or Steam Sterilization

[00810131880910]

Moist Heat or Steam Sterilization

[00810131880910]

Moist Heat or Steam Sterilization

[00810131880910]

Moist Heat or Steam Sterilization

[00810131880910]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-17
• Device Publish Date: 2024-12-09

Devices Manufactured by SURGENTEC, LLC

• 00858406007259 - 6mm Dilator: 2024-12-26
• 00858406007266 - 10mm Dilator: 2024-12-26
• 00858406007273 - 17mm Dilator: 2024-12-26
• 00858406007280 - 20mm Dilator: 2024-12-26
• 00858406007532 - 13mm Dilator: 2024-12-26
• 00858406007631 - GraftRasp Sterilization Tray: 2024-12-26
• 00858406007716 - 3/4 inch Cobb: 2024-12-26
• 00810131880910 - Guide Pin - Bevel: 2024-12-17
• 00810131880910 - Guide Pin - Bevel: 2024-12-17