SoftLink Button

GUDID 00810020083057

Suture Button Loop

RIVERPOINT MEDICAL, LLC

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 00810020083057
• NIH Device Record Key: 234e2b2a-6e77-4579-af54-73f3ca408ed6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SoftLink Button
• 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: 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	00810020083057 [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: 2020-04-07
• Device Publish Date: 2020-03-30

Devices Manufactured by RIVERPOINT MEDICAL, LLC

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• 00840277404909 - OrthoButton FL: 2024-04-24 Suture Button Loop
• 00840277404916 - OrthoButton FL: 2024-04-24 Suture Button Loop
• 10840277404777 - HS Fiber: 2024-03-19 Suture
• 10840277404784 - HS Fiber: 2024-03-19 Suture
• 10840277404791 - HS Fiber: 2024-03-19 Suture
• 10840277404807 - HS Fiber: 2024-03-19 Suture