| Primary Device ID | 05708265013340 |
| NIH Device Record Key | 32e4c04e-a077-44d4-9435-71d43a820d39 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LiNA Xcise™, Laparoscopic Morcellator |
| Version Model Number | MOR-1515-6 |
| Catalog Number | MOR-1515-6 |
| Company DUNS | 305088619 |
| Company Name | Lina Medical ApS |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | 05708265013333 [Primary] |
| GS1 | 05708265013340 [Package] Contains: 05708265013333 Package: [6 Units] In Commercial Distribution |
| HET | Laparoscope, Gynecologic (And Accessories) |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-01 |
| Device Publish Date | 2024-09-23 |
| 05708265004713 | 15mm battery powered morcellator system with obturator |
| 05708265004515 | 15mm battery powered morcellator system with obturator |
| 05708265012534 | 15mm battery powered morcellator system with obturator |
| 05708265013340 | 15mm battery powered morcellator system with obturator |
| 05708265013326 | 15mm battery powered morcellator system with obturator |