| Primary Device ID | 00854629006857 |
| NIH Device Record Key | df5f5271-93c3-4558-bce6-983208ac40a7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fastloop™ Green |
| Version Model Number | DFX24SLG |
| Company DUNS | 079471560 |
| Company Name | DUNAMIS MEDICAL, LLC |
| Device Count | 12 |
| 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 |
| Phone | 877.454.2186 |
| info@dunamismedical.com | |
| Phone | 877.454.2186 |
| info@dunamismedical.com | |
| Phone | 877.454.2186 |
| info@dunamismedical.com | |
| Phone | 877.454.2186 |
| info@dunamismedical.com | |
| Phone | 877.454.2186 |
| info@dunamismedical.com | |
| Phone | 877.454.2186 |
| info@dunamismedical.com | |
| Phone | 877.454.2186 |
| info@dunamismedical.com | |
| Phone | 877.454.2186 |
| info@dunamismedical.com | |
| Phone | 877.454.2186 |
| info@dunamismedical.com | |
| Phone | 877.454.2186 |
| info@dunamismedical.com | |
| Phone | 877.454.2186 |
| info@dunamismedical.com | |
| Phone | 877.454.2186 |
| info@dunamismedical.com | |
| Phone | 877.454.2186 |
| info@dunamismedical.com | |
| Phone | 877.454.2186 |
| info@dunamismedical.com | |
| Phone | 877.454.2186 |
| info@dunamismedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00854629006857 [Unit of Use] |
| GS1 | 10854629006854 [Primary] |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-03-11 |
| Device Publish Date | 2022-03-03 |
| 00850052601317 - Olecranon Transporter™ Repair Kit | 2025-05-07 Olecranon Transporter™ Repair Kit |
| 00850052601294 - Force DFX Suture Loop -Xtreme™ | 2025-04-18 Force DFX Suture Loop-Xtreme™ |
| 00850052601256 - Micro Constrictor ®X Repair Kit | 2024-09-27 Micro Constrictor ® X Repair Kit |
| 00850052601263 - Constrictor® Mini 2.0 Syndesmosis Repair Kit | 2024-09-27 Constrictor® Mini 2.0 Syndesmosis Repair Kit |
| 00850052601270 - Constrictor® 2.0 Syndesmosis Repair Kit | 2024-09-27 Constrictor® 2.0Syndesmosis Repair Kit |
| 00854629006789 - Constrictor® Mini Syndesmosis Repair Kit | 2024-09-27 Constrictor® Mini Syndesmosis Repair Kit |
| 00850052601249 - Orca™ Implantation Kit | 2024-06-28 Orca™ Implantation Kit |
| 00850052601072 - Hallux Guide | 2024-06-18 Hallux Guide |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() FASTLOOP 90905400 not registered Live/Pending |
Dunamis Medical Technologies, LLC 2021-08-26 |