TiLink-P Screw 12mm x 25mm

GUDID 00810131880842

SURGENTEC, LLC

Laparoscopic access cannula anchor, single-use

• Primary Device ID: 00810131880842
• NIH Device Record Key: 63ba5a48-ec32-4636-9eec-edf4dbca3657
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TiLink-P Screw 12mm x 25mm
• Version Model Number: SI-SGT-25
• 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: 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	00810131880842 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242141

FDA Product Code

• OUR: Sacroiliac Joint Fixation

Sterilization

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

[00810131880842]

Moist Heat or Steam Sterilization

[00810131880842]

Moist Heat or Steam Sterilization

[00810131880842]

Moist Heat or Steam Sterilization

[00810131880842]

Moist Heat or Steam Sterilization

[00810131880842]

Moist Heat or Steam Sterilization

[00810131880842]

Moist Heat or Steam Sterilization

[00810131880842]

Moist Heat or Steam Sterilization

[00810131880842]

Moist Heat or Steam Sterilization

[00810131880842]

Moist Heat or Steam Sterilization

[00810131880842]

Moist Heat or Steam Sterilization

[00810131880842]

Moist Heat or Steam Sterilization

[00810131880842]

Moist Heat or Steam Sterilization

[00810131880842]

Moist Heat or Steam Sterilization

[00810131880842]

Moist Heat or Steam Sterilization

[00810131880842]

Moist Heat or Steam Sterilization

[00810131880842]

Moist Heat or Steam Sterilization

[00810131880842]

Moist Heat or Steam Sterilization

[00810131880842]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-05
• Device Publish Date: 2025-04-25

Devices Manufactured by SURGENTEC, LLC

• 00810131881375 - ALARA 11 Gauge Access Needle with Sheath - Bevel Tip: 2025-05-07
• 00810131881382 - ALARA 11 Gauge Access Needle with Sheath - Diamond Tip: 2025-05-07
• 00850040139471 - ALARA® 11 Gauge Access Needle - Bevel Tip: 2025-05-07
• 00850040139488 - ALARA® 11 Gauge Access Needle - Diamond Tip: 2025-05-07
• 00850040139495 - ALARA® 11 Gauge Access Needle Two Pack- Bevel Tip: 2025-05-07
• 00850040139501 - ALARA® 11 Gauge Access Needle Two Pack- Diamond & Bevel Tip: 2025-05-07
• 00850040139518 - ALARA® 11 Gauge Access Needle Two Pack- Diamond Tip: 2025-05-07
• 00850040139525 - ALARA® 11 Gauge Access Needle with Sheath - Bevel Tip: 2025-05-07