| Primary Device ID | 00850033131086 |
| NIH Device Record Key | 521a426e-f32c-49cb-97d0-6290e664cdf8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RegenLab USA |
| Version Model Number | R-ET |
| Company DUNS | 087434117 |
| Company Name | Regenlab USA LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850033131086 [Primary] |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00850033131086]
Radiation Sterilization
[00850033131086]
Radiation Sterilization
[00850033131086]
Radiation Sterilization
[00850033131086]
Radiation Sterilization
[00850033131086]
Radiation Sterilization
[00850033131086]
Radiation Sterilization
[00850033131086]
Radiation Sterilization
[00850033131086]
Radiation Sterilization
[00850033131086]
Radiation Sterilization
[00850033131086]
Radiation Sterilization
[00850033131086]
Radiation Sterilization
[00850033131086]
Radiation Sterilization
[00850033131086]
Radiation Sterilization
[00850033131086]
Radiation Sterilization
[00850033131086]
Radiation Sterilization
[00850033131086]
Radiation Sterilization
[00850033131086]
Radiation Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-05-08 |
| Device Publish Date | 2023-04-28 |
| 00850033131086 | R-ET |
| 00850033131079 | RK-WG-2 |
| 00850033131062 | RK-THT-3-20-U |
| 00850033131055 | RK-THT-3-U |
| 00850033131048 | RK-BCT-3-20-U |
| 00850033131031 | RK-BCT-3-U |
| 00850033131109 | RegenKit-THT-BMC, Ref: RK-THT-BMC-3-10 |