| 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 |