BightForce A40 BFT15

GUDID 00810021861548

BightForce High Strength Suture Tape, 1.5 mm X 38"

IN2BONES USA, LLC

Soft-tissue/mesh anchor, non-bioabsorbable

• Primary Device ID: 00810021861548
• NIH Device Record Key: 46613d7b-e059-4417-8b01-0818f0a276e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BightForce
• Version Model Number: A40 BFT15
• Catalog Number: A40 BFT15
• Company DUNS: 079700711
• Company Name: IN2BONES USA, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810021861548 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201636

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: 2024-12-17
• Device Publish Date: 2024-12-09

On-Brand Devices [BightForce]

• 00810021861555: BightForce High Strength Suture Tape, 2.0 mm X 36"
• 00810021861548: BightForce High Strength Suture Tape, 1.5 mm X 38"