| Primary Device ID | 00854629006260 |
| NIH Device Record Key | 8d9d2c79-2dac-41a0-a6b5-9b898282c90d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PunchTac 5.5mm Anchor PEEK |
| Version Model Number | DFX0035A |
| Catalog Number | DFX0035A |
| Company DUNS | 079471560 |
| Company Name | DUNAMIS MEDICAL, LLC |
| Device Count | 1 |
| DM Exempt | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00854629006253 [Primary] |
| GS1 | 00854629006260 [Package] Contains: 00854629006253 Package: Box [5 Units] In Commercial Distribution |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-04-12 |
| 00854629006260 | 5.5mm PunchTac™ Threaded Anchor PEEK Preloaded with Two 2mm DFX Tensile Tape (UHMWPE) S |
| 00854629006192 | Suture Anchor 5.5 PEEK Sterile Double Loaded Sutures #2 White/Blue Cobraid #2 White/Black Cobr |