| Primary Device ID | 00854629006819 | 
| NIH Device Record Key | d9452997-2323-497f-9b78-4fea9fe012bc | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Constrictor® Rope | 
| Version Model Number | DLF 002 | 
| Catalog Number | DLF 002 | 
| Company DUNS | 079471560 | 
| Company Name | DUNAMIS 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 | true | 
| 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 | true | 
| 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 | |
| Phone | 877.454.2186 | 
| info@dunamismedical.com | |
| Phone | 877.454.2186 | 
| info@dunamismedical.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00854629006819 [Primary] | 
| HTN | Washer, Bolt Nut | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2021-12-29 | 
| Device Publish Date | 2021-12-21 | 
| 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 |