Colink Adjustable Loop

GUDID 00812444028430

Suture Button Loop

RIVERPOINT MEDICAL, LLC

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 00812444028430
• NIH Device Record Key: 94d7fe81-89c0-4d0d-b2a8-574e70f4ceda
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Colink Adjustable Loop
• Version Model Number: TEK-OBAL-80
• Company DUNS: 964053560
• Company Name: RIVERPOINT MEDICAL, 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812444028430 [Primary]

FDA Product Code

• MBI: Fastener, Fixation, Nondegradable, Soft Tissue

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-03-21
• Device Publish Date: 2018-07-05

Devices Manufactured by RIVERPOINT MEDICAL, LLC

• 10810020085225 - HS Fiber: 2024-08-15 Suture Tape
• 10810020083672 - HS Fiber: 2024-08-08 Suture
• 00840277404756 - Iconix: 2024-08-05 Iconix Knotless, 1.4mm Anchor with XBraid™ S (Blue/Black/White)
• 00840277404763 - Iconix: 2024-08-05 Iconix Knotless, 2.3mm Anchor with #2 XBraid S (Blue/Black)
• 10812444029441 - HS FIber: 2024-06-26 Suture Tape
• 00810020080285 - OrthoButton CL: 2024-05-24 Continuous Loop with Titanium Button
• 00810020080292 - OrthoButton CL: 2024-05-24 Continuous Loop with Titanium Button
• 00810020080308 - OrthoButton CL: 2024-05-24 Continuous Loop with Titanium Button