| Primary Device ID | 00810050855648 |
| NIH Device Record Key | e8c8e2d1-fcbd-4d55-801b-f70778a80d13 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Rad Control |
| Version Model Number | RT0301XVT |
| Company DUNS | 600850213 |
| Company Name | TYPENEX MEDICAL LLC |
| Device Count | 200 |
| 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 | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810050855648 [Unit of Use] |
| GS1 | 00810050855655 [Primary] |
| GS1 | 10810050855652 [Package] Contains: 00810050855655 Package: Pallet [25 Units] In Commercial Distribution |
| IWZ | Film, Radiographic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-07-23 |
| Device Publish Date | 2024-07-15 |
| 00892159002178 | 15 Gy Irradiation Indicator Tag - X Ray |
| 00892159002161 | 25 Gy Irradiation Indicator Tag - X Ray |
| 00892159002154 | 15 Gy Irradiation Indicator Tag - Gamma |
| 00892159002109 | 25 Gy Irradiation Indicator Tag - Gamma |
| 00851878008892 | 25 Gy Irradiation Indicator Tag - X Ray - Custom One Blood |
| 00851878008885 | 25 Gy Irradiation Indicator Tag - Gamma - Custom One Blood |
| 00812269033374 | Irradiation Indicator Tag - Barcode Indicator |
| 00812269033350 | 25 - 50 GY Irradiation Indicator Tag |
| 00812269033343 | 15 - 50 GY Irradiation Indicator Tag |
| 00812269030014 | 25 Gy Irradiation Indicator Tag - X Ray (no sticker) |
| 00812269030007 | 25 Gy Irradiation Indicator Tag - Gamma (No Sticker) |
| 00810050855648 | 25 Gy Universal Irradiation Tag (RT0301XVT) |