| Primary Device ID | 08057276004821 | 
| NIH Device Record Key | 42955327-a309-41d6-86a6-5ace7a21a9e4 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Bone-HarvestOR | 
| Version Model Number | PS0810 | 
| Catalog Number | PS0810 | 
| 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 | 
| Length | 100 Millimeter | 
| Needle Gauge | 8 Gauge | 
| Length | 100 Millimeter | 
| Needle Gauge | 8 Gauge | 
| Length | 100 Millimeter | 
| Needle Gauge | 8 Gauge | 
| Length | 100 Millimeter | 
| Needle Gauge | 8 Gauge | 
| Length | 100 Millimeter | 
| Needle Gauge | 8 Gauge | 
| Length | 100 Millimeter | 
| Needle Gauge | 8 Gauge | 
| Length | 100 Millimeter | 
| Needle Gauge | 8 Gauge | 
| Length | 100 Millimeter | 
| Needle Gauge | 8 Gauge | 
| Length | 100 Millimeter | 
| Needle Gauge | 8 Gauge | 
| Length | 100 Millimeter | 
| Needle Gauge | 8 Gauge | 
| Length | 100 Millimeter | 
| Needle Gauge | 8 Gauge | 
| Length | 100 Millimeter | 
| Needle Gauge | 8 Gauge | 
| Length | 100 Millimeter | 
| Needle Gauge | 8 Gauge | 
| Length | 100 Millimeter | 
| Needle Gauge | 8 Gauge | 
| Length | 100 Millimeter | 
| Needle Gauge | 8 Gauge | 
| Length | 100 Millimeter | 
| Needle Gauge | 8 Gauge | 
| Length | 100 Millimeter | 
| Needle Gauge | 8 Gauge | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 08057276004821 [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 | 2025-05-07 MULTIRADIAL SELECTIVE HARVESTING SYSTEM OF AUTOLOGOUS BONE MARROW 11G x 100 mm | 
| 08057276004821 - Bone-HarvestOR | 2025-05-07AUTOLOGOUS BONE HARVESTING SYSTEM 08G 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 |