OrthoButton AL

GUDID 00812444026986

Soft tissue fixation device

RIVERPOINT MEDICAL, LLC

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 00812444026986
• NIH Device Record Key: d28e6565-e56b-46a7-b6a0-b4f6e6a433d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OrthoButton AL
• Version Model Number: RP-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: false
• 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	00812444026986 [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: 2019-11-13
• Device Publish Date: 2019-11-05

On-Brand Devices [OrthoButton AL]

• 00812444026245: Suture Button Loop
• 00812444026986: Soft tissue fixation device
• 10840277402964: Suture Button Loop