| Primary Device ID | 05708265000845 |
| NIH Device Record Key | 4f9c116a-f347-45cc-98c1-10a96620f25b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LiNA SeaStar™ |
| Version Model Number | 4000-S-SL |
| Catalog Number | 4000-S-SL |
| Company DUNS | 305088619 |
| Company Name | Lina Medical ApS |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | +48612222122 |
| info.poland@lina-medical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05708265000432 [Primary] |
| GS1 | 05708265000845 [Package] Contains: 05708265000432 Package: box [5 Units] In Commercial Distribution |
| GAD | Retractor |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-15 |
| 05708265002269 | single use retractor ring; Squared model |
| 05708265000883 | single use retractor ring VV model (V-shape/V-shape) |
| 05708265000876 | single use retractor ring; VS model (V-shape/Small) |
| 05708265000869 | single use retractor ring; VL model (V-shape/Large) |
| 05708265000852 | single use retractor ring; SS model (Small/Small) |
| 05708265000845 | single use retractor ring; SL model (Small/Large) |