| Primary Device ID | 07640138981012 |
| NIH Device Record Key | c6c11029-6c0a-41c0-aa6a-57553eacb731 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RegenET |
| Version Model Number | R-ET-3x20 |
| Company DUNS | 482206518 |
| Company Name | REGEN LAB SA |
| 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 | true |
| 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 |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07640138981012 [Primary] |
| KJC | Bottle, Roller, Tissue Culture |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-07-06 |
| Device Publish Date | 2022-06-28 |
| 07640138981364 | R-ET-3 |
| 07640138981012 | Kit containing 20 x R-ET-3 in a carton box |