FDA UDI
In Commercial Distribution
🇺🇸 United States
SeleneView®
DI: 06975339623227
·
Model: HO42
·
MacroLux Medical Technology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- SeleneView®
- Primary DI
- 06975339623227
- Version / Model
- HO42
- Company Name
- MacroLux Medical Technology Co., Ltd.
- Labeler DUNS
- 723490133
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-23
- Public Version
- 2
- Public Version Date
- 2025-12-22
- Public Version Status
- Update
- Public Device Record Key
- b0ffdb54-9635-4de4-9280-ea6d20da6e90
Device Description
SeleneView®, Single-Use Digital Hysteroscope, HO42
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HIH | Hysteroscope (And Accessories) | Obstetrics/Gynecology | 884.1690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63256 | Rigid video hysteroscope | An electrically-powered endoscope with a rigid inserted portion (which may have a flexible-tip) intended for visual examination and treatment of the cervix canal and uterine cavity (uterus), or for removal of an early or non-viable embryo/foetus upon connection to an abortion suction system. It is inserted through the vagina during hysteroscopy; some types are also intended for insertion into the female urethra during cystoscopy. An image sensor chip at the distal end of the device transmits the video images to a display monitor. It is commonly used to evaluate/treat fibroids (myomas), polyps, or conditions related to the menstrual period (e.g., menorrhagia). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16975339623224 | GS1 | Carton | 10 | In Commercial Distribution | |
| Primary | 06975339623227 | GS1 |