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
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" |
Trademark Results [BightForce]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIGHTFORCE 88390077 not registered Live/Pending |
In2Bones USA, LLC 2019-04-17 |
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