| Primary Device ID | 00850052601232 |
| NIH Device Record Key | 8e622eb3-d366-4060-88dc-68a9a93a4727 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Micro Constrictor® Implantation Kit |
| Version Model Number | AB-8250 |
| Catalog Number | AB-6950 |
| Company DUNS | 079471560 |
| Company Name | DUNAMIS MEDICAL, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850052601232 [Primary] |
| HTW | Bit, Drill |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-06-18 |
| Device Publish Date | 2024-06-10 |
| 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 |
| 00850052601089 - CMC Spacer | 2024-06-18 CMC Spacer |
| 00850052601096 - CMC Guide | 2024-06-18 CMC Guide |