| Primary Device ID | 00850033131093 |
| NIH Device Record Key | d94786a4-eb6f-4145-91ff-6a42065ea024 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RegenKit Wound-Gel |
| Version Model Number | RK-WG-1 |
| Catalog Number | SE-RK-WG-1 |
| 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 | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850033131093 [Primary] |
| PMQ | Peripheral Blood Processing Device For Wound Management |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-20 |
| Device Publish Date | 2024-03-12 |
| 00850033131116 - Enhanced HA | 2025-09-08 |
| 00850033131123 - Wound Care Accessory Set | 2025-08-18 |
| 00850033131109 - RegenLab USA | 2024-04-26 RegenKit-THT-BMC, Ref: RK-THT-BMC-3-10 |
| 00850033131093 - RegenKit Wound-Gel | 2024-03-20. |
| 00850033131093 - RegenKit Wound-Gel | 2024-03-20 . |
| 00850033131031 - RegenLab USA | 2023-05-08 |
| 00850033131048 - RegenLab USA | 2023-05-08 |
| 00850033131055 - RegenLab USA | 2023-05-08 |
| 00850033131062 - RegenLab USA | 2023-05-08 |