| Primary Device ID | 08057276004814 |
| NIH Device Record Key | 1fa741a1-8534-422e-8741-dd5e1218cc71 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cell-HarvestOR |
| Version Model Number | PSH1D21110 |
| Catalog Number | PSH1D21110 |
| Company DUNS | 447228586 |
| Company Name | M.D.L. S.R.L. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08057276004814 [Primary] |
| DWO | Needle, Biopsy, Cardiovascular |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-07 |
| Device Publish Date | 2025-04-29 |
| 08057276004814 - Cell-HarvestOR | 2025-05-07MULTIRADIAL SELECTIVE HARVESTING SYSTEM OF AUTOLOGOUS BONE MARROW 11G x 100 mm |
| 08057276004814 - Cell-HarvestOR | 2025-05-07 MULTIRADIAL SELECTIVE HARVESTING SYSTEM OF AUTOLOGOUS BONE MARROW 11G x 100 mm |
| 08057276004821 - Bone-HarvestOR | 2025-05-07 AUTOLOGOUS BONE HARVESTING SYSTEM 08G x 100 mm |
| 08056138586338 - MarkX | 2025-03-10 NON-REPOSITIONAL DISPOSABLE NEEDLE 20G x 100 mm FOR MAMMARY NODULE LOCALIZATION, WITH DOUBLE HOOK |
| 08057276004715 - MarkX | 2025-03-10 NON-REPOSITIONAL DISPOSABLE NEEDLE 20G x 150 mm FOR MAMMARY NODULE LOCALIZATION, WITH DOUBLE HOOK |
| 28056138586721 - Themy | 2021-06-01 DISPOSABLE AUTOMATIC DEVICE 18G X 100 mm FOR SOFT TISSUE BIOPSY, NOTCH OF 20 mm |