| Primary Device ID | 16975339623194 |
| NIH Device Record Key | 44593993-5b40-4af0-93e1-0927b8fb7dd2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SeleneView® |
| Version Model Number | HC35-G |
| Company DUNS | 723490133 |
| Company Name | MacroLux Medical Technology Co., Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | 06975339623197 [Primary] |
| GS1 | 16975339623194 [Package] Contains: 06975339623197 Package: Carton [10 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 | 2024-09-02 |
| Device Publish Date | 2024-08-23 |
| 16975339623231 | SeleneView®, Single-Use Digital Hysteroscope, HO42-G |
| 16975339623224 | SeleneView®, Single-Use Digital Hysteroscope, HO42 |
| 16975339623217 | SeleneView®, Single-Use Digital Hysteroscope, HO35-G |
| 16975339623200 | SeleneView®, Single-Use Digital Hysteroscope, HO35 |
| 16975339623194 | SeleneView®, Single-Use Digital Hysteroscope, HC35-G |
| 16975339623187 | SeleneView®, Single-Use Digital Hysteroscope, HC35 |
| 16975339623170 | SeleneView®, Single-Use Digital Hysteroscope, HC29-G |
| 06975339623166 | SeleneView®, Single-Use Digital Hysteroscope, HC29 |