TILink-P Instrument Removal Tool

GUDID 00810131880347

SURGENTEC, LLC

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 00810131880347
• NIH Device Record Key: d47cc814-2416-41dc-95f5-466618f4a628
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TILink-P Instrument Removal Tool
• Version Model Number: SR16-3800
• Company DUNS: 004095409
• Company Name: SURGENTEC, LLC
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810131880347 [Primary]

FDA Product Code

• OUR: Sacroiliac Joint Fixation

Sterilization

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

[00810131880347]

Moist Heat or Steam Sterilization

[00810131880347]

Moist Heat or Steam Sterilization

[00810131880347]

Moist Heat or Steam Sterilization

[00810131880347]

Moist Heat or Steam Sterilization

[00810131880347]

Moist Heat or Steam Sterilization

[00810131880347]

Moist Heat or Steam Sterilization

[00810131880347]

Moist Heat or Steam Sterilization

[00810131880347]

Moist Heat or Steam Sterilization

[00810131880347]

Moist Heat or Steam Sterilization

[00810131880347]

Moist Heat or Steam Sterilization

[00810131880347]

Moist Heat or Steam Sterilization

[00810131880347]

Moist Heat or Steam Sterilization

[00810131880347]

Moist Heat or Steam Sterilization

[00810131880347]

Moist Heat or Steam Sterilization

[00810131880347]

Moist Heat or Steam Sterilization

[00810131880347]

Moist Heat or Steam Sterilization

[00810131880347]

Moist Heat or Steam Sterilization

[00810131880347]

Moist Heat or Steam Sterilization

[00810131880347]

Moist Heat or Steam Sterilization

[00810131880347]

Moist Heat or Steam Sterilization

[00810131880347]

Moist Heat or Steam Sterilization

[00810131880347]

Moist Heat or Steam Sterilization

[00810131880347]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-26
• Device Publish Date: 2024-08-16

On-Brand Devices [TILink-P Instrument Removal Tool]

• 00850040139976: SR16-6800
• 00810131880347: SR16-3800