| Primary Device ID | D20230209 |
| NIH Device Record Key | 2119b39a-2eaa-43b6-98b7-d65ed9d4f254 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EZPRF |
| Version Model Number | EZ4K |
| Company DUNS | 015144539 |
| Company Name | CosmoFrance |
| Device Count | 4 |
| 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 | false |
| Manufacturing Date | true |
| 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 |
|---|---|
| HIBCC | D20230209 [Unit of Use] |
| HIBCC | G589EZ4K4 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-04 |
| Device Publish Date | 2024-02-23 |
| D20230209 | EZ4K |
| G589EZ2K2 | EZ2K |
| G589EZ4K1 | EZ4K |
| G589EZ2K1 | EZ2K |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() EZPRF 87379013 5638636 Live/Registered |
ECTODERMA INC 2017-03-21 |