| Primary Device ID | 00855204008099 |
| NIH Device Record Key | 4a6f22a4-9e2a-4c3a-a307-171e4c2e65e8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EZ GAUZE |
| Version Model Number | TM-215 |
| Catalog Number | TM-215 |
| Company DUNS | 078589992 |
| Company Name | TYTEK MEDICAL INC. |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | true |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00855204008099 [Primary] |
| NAB | Gauze / Sponge,Nonresorbable For External Use |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-10-11 |
| Device Publish Date | 2019-10-03 |
| 00860010987902 - Surgical HypoHolder | 2025-07-07 Magnetic pin and handle base |
| 00860010987940 - Clinical HypoHolder | 2025-07-07 Non-sterile pin base for use in clinical setting |
| 00860010987926 - HypoPan | 2025-06-25 Autoclave pan and tray for Surgical HypoHolder |
| 00860013471606 - HypoFoam | 2025-06-25 Single-use foam block for use with HypoHolder system |
| 00855204008006 - TPAK | 2019-10-11 Tension Pneumothorax Decompression Needle: 14 gauge x 3.25" |
| 00855204008013 - TVAC | 2019-10-11 Disposable portable suction unit |
| 00855204008020 - Ptensys Bleeding Control Station | 2019-10-11 Ptensys Bleeding Control Station |
| 00855204008037 - Ptensys Bleeding Control Kits | 2019-10-11 Ptensys Bleeding Control Kits |