| Primary Device ID | 05708265012404 |
| NIH Device Record Key | 37582daa-c9b6-45ad-b251-6327a9e4d9c3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LiNA OperåScope™ with HDMI cable & LCD |
| Version Model Number | OP-201-6 |
| 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 | 05708265012398 [Primary] |
| GS1 | 05708265012404 [Package] Contains: 05708265012398 Package: [6 Units] In Commercial Distribution |
| HIH | Hysteroscope (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 | 2020-09-14 |
| Device Publish Date | 2020-09-04 |
| 05708265010950 | OP‐201‐6 |
| 05708265010318 | OP‐201‐6 |
| 05708265010295 | OP‐201‐1 |
| 05708265011940 | OP-201-6 |
| 05708265012404 | LiNA OperåScope™ with HDMI cable & LCD intended for hysteroscopy and cystoscopy |
| 05708265013418 | LiNA OperåScope™ with HDMI cable & LCD intended for hysteroscopy and cystoscopy |
| 05708265013913 | LiNA OperåScope™ with HDMI cable & LCD intended for hysteroscopy and cystoscopy |