| Primary Device ID | 10860012426307 |
| NIH Device Record Key | 62663e6b-a5e3-443c-9633-bee5cbbe7fba |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tomahawk Safety |
| Version Model Number | 91030 |
| Company DUNS | 113491907 |
| Company Name | TOMAHAWK SAFETY, 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860012426300 [Primary] |
| GS1 | 10860012426307 [Package] Contains: 00860012426300 Package: Inner Pack [10 Units] In Commercial Distribution |
| GS1 | 20860012426304 [Package] Contains: 00860012426300 Package: Case [100 Units] In Commercial Distribution |
| OEA | Non-Surgical Gown |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-06 |
| Device Publish Date | 2024-07-29 |
| 10860012426314 | Tomahawk USA AAMI Level 2 Isolation Gown (Non-Surgical), X-Large |
| 10860012426307 | Tomahawk USA AAMI Level 2 Isolation Gown (Non-Surgical), Large |