| Primary Device ID | 05708265010264 |
| NIH Device Record Key | 44954e76-0b8e-4f20-bbee-6aa0736eae37 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LiNA OperaScope™ with HDMI cable |
| Version Model Number | OP-200-6 |
| 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 |
| Phone | +48 612222149 |
| info.poland@lina-medical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05708265010264 [Primary] |
| GS1 | 05708265010271 [Package] Package: box [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 | 2020-03-30 |
| Device Publish Date | 2020-03-20 |
| 05708265010264 | LiNA OperaScope™ with HDMI cable, without on-board LCD screen |
| 05708265012381 | LiNA OperaScope™ with HDMI cable, without on-board LCD screen, intended for hysteroscopy and c |
| 05708265013395 | LiNA OperaScope™ with HDMI cable, without on-board LCD screen, intended for hysteroscopy and c |