RootMend™ MRR Soft Button (Black)

GUDID 00840277405647

Adjustable Loop

RIVERPOINT MEDICAL, LLC

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 00840277405647
• NIH Device Record Key: 39f683c3-0ece-402d-9f9a-b999f8e43c5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RootMend™ MRR Soft Button (Black)
• Version Model Number: 104.000
• Company DUNS: 964053560
• Company Name: RIVERPOINT MEDICAL, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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	00840277405647 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243988

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: 2025-05-09
• Device Publish Date: 2025-05-01

Devices Manufactured by RIVERPOINT MEDICAL, LLC

• 00840277409461 - ApeCord: 2025-06-06 Black UHMWPE Polyblend Non-Absorbable Suture
• 00840277409478 - ApeCord: 2025-06-06 White/Black UHMWPE Polyblend Non-Absorbable Suture
• 00840277409485 - ApeCord: 2025-06-06 Black UHMWPE Polyblend Non-Absorbable Suture
• 00840277409492 - ApeCord: 2025-06-06 White/Black UHMWPE Polyblend Non-Absorbable Suture
• 00840277409508 - ApeCord: 2025-06-06 Black UHMWPE Polyblend Non-Absorbable Suture
• 00840277409515 - ApeCord: 2025-06-06 White/Black UHMWPE Polyblend Non-Absorbable Suture
• 00840277409522 - ApeCord: 2025-06-06 Black UHMWPE Polyblend Non-Absorbable Suture
• 00840277409539 - ApeCord: 2025-06-06 White/Black UHMWPE Polyblend Non-Absorbable Suture