| Primary Device ID | 05708265010592 |
| NIH Device Record Key | 8e920fc9-30f6-42ea-a082-10d67e271f15 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LiNA OperaScope™ Tubing & Drape kit |
| Version Model Number | OP-TDK-6 |
| Catalog Number | OP-TDK-6 |
| 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 | +48 612222149 |
| info.poland@lina-medical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05708265010585 [Primary] |
| GS1 | 05708265010592 [Package] Contains: 05708265010585 Package: [6 Units] In Commercial Distribution |
| NVT | Tubing And Tubing/Filter Fits |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-04-09 |
| Device Publish Date | 2018-04-11 |
| 05708265010592 | Tubing & drape for hysteroscopy |
| 05708265011858 | Tubing & drape for hysteroscopy |
| 05708265011186 | Tubing & drape for hysteroscopy |
| 05708265012480 | Tubing & drape Kit intended for hysteroscopy and cystoscopy |