| Primary Device ID | 08057276004715 | 
| NIH Device Record Key | 1b4491a1-2bc8-49cc-847a-bf96b25ba7fd | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | MarkX | 
| Version Model Number | PNX2015 | 
| Catalog Number | PNX2015 | 
| 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 | 
| Needle Gauge | 20 Gauge | 
| Length | 150 Millimeter | 
| Needle Gauge | 20 Gauge | 
| Length | 150 Millimeter | 
| Needle Gauge | 20 Gauge | 
| Length | 150 Millimeter | 
| Needle Gauge | 20 Gauge | 
| Length | 150 Millimeter | 
| Needle Gauge | 20 Gauge | 
| Length | 150 Millimeter | 
| Needle Gauge | 20 Gauge | 
| Length | 150 Millimeter | 
| Needle Gauge | 20 Gauge | 
| Length | 150 Millimeter | 
| Needle Gauge | 20 Gauge | 
| Length | 150 Millimeter | 
| Needle Gauge | 20 Gauge | 
| Length | 150 Millimeter | 
| Needle Gauge | 20 Gauge | 
| Length | 150 Millimeter | 
| Needle Gauge | 20 Gauge | 
| Length | 150 Millimeter | 
| Needle Gauge | 20 Gauge | 
| Length | 150 Millimeter | 
| Needle Gauge | 20 Gauge | 
| Length | 150 Millimeter | 
| Needle Gauge | 20 Gauge | 
| Length | 150 Millimeter | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 08057276004715 [Primary] | 
| GS1 | 18057276004712 [Package] Package: [10 Units] In Commercial Distribution | 
| GDF | Guide, Needle, Surgical | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2025-03-10 | 
| Device Publish Date | 2025-02-28 | 
| 08057276004715 | NON-REPOSITIONAL DISPOSABLE NEEDLE 20G x 150 mm FOR MAMMARY NODULE LOCALIZATION, WITH DOUBLE HOO | 
| 08056138586338 | NON-REPOSITIONAL DISPOSABLE NEEDLE 20G x 100 mm FOR MAMMARY NODULE LOCALIZATION, WITH DOUBLE HOO |