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 |