Fixion Button Loop

GUDID 00810020082258

Suture Button Loop

RIVERPOINT MEDICAL, LLC

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 00810020082258
• NIH Device Record Key: 718f75fa-4fb5-4fc3-9141-0f44183e50da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fixion Button Loop
• Version Model Number: G25 BF20
• 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	00810020082258 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-14
• Device Publish Date: 2020-02-06

On-Brand Devices [Fixion Button Loop]

• 00810020082937: Suture Button Loop
• 00810020082272: Suture Button Loop
• 00810020082265: Suture Button Loop
• 00810020082258: Suture Button Loop
• 00810020082241: Suture Button Loop
• 00810020082234: Suture Button Loop