| Primary Device ID | 05708265004614 |
| NIH Device Record Key | 8caef01c-0fa6-41bb-bfaa-7ac6bcf90470 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LiNA Bipolar Loop™ |
| Version Model Number | BL-160 |
| Catalog Number | BL-160 |
| 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 |
| Phone | +48 612222134 |
| info.poland@lina-medical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05708265004607 [Primary] |
| GS1 | 05708265004614 [Package] Contains: 05708265004607 Package: box [6 Units] In Commercial Distribution |
| HIN | Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-02-07 |
| Device Publish Date | 2016-09-15 |
| 05708265004652 | Endoscopic Bipolar Loop for Laparoscopic Supracervical Hysterectomy and Myomectomy. X-Large Loop |
| 05708265004638 | Endoscopic Bipolar Loop for Laparoscopic Supracervical Hysterectomy and Myomectomy. Large Loop- |
| 05708265004614 | Endoscopic Bipolar Loop for Laparoscopic Supracervical Hysterectomy and Myomectomy. Small Loop- |