WomanCare Global Uterine Evacuation Kit
Each kit contains one Ipas Double-Valve Aspirator, 4 Ipas EasyGrip® Cannulae : 6mm, 7mm, 8mm and 9 mm, 3 Denniston Dilators: 5/6mm, 7/8mm and 9/10 mm.
1manufacturer
1catalogue number
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Suyun Medical Materials Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 11 |
Record
| Listed by | Womancare Global Trading, Inc. |
|---|---|
| FDA product code | HHI |
| Device type | System, Abortion, Vacuum |
| Device class | Class 2 |
| Regulation | 21 CFR 884.5070 |
| Premarket notification | Exempt |
| Record published | 2016-09-17 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature 15 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| UEK-SU | Dilators : 5/6mm, 7/8mm, 9/10mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| System, Abortion, Vacuum | Richard Wolf Gmbh | 3 |
| WomanCare Global Single-Valve Aspirator | Womancare Global Trading, Inc. | 2 |
| Gynex | Gynex Corporation | 2 |
| WomanCare Global Double-Valve Aspirator | Womancare Global Trading, Inc. | 2 |
| medgyn collection set | Medgyn Products, Inc. | 2 |
| WomanCare Global Miscarriage Management Kit | Womancare Global Trading, Inc. | 1 |
| WomanCare Global Ipas MVA Plus Aspirator | Womancare Global Trading, Inc. | 1 |
| MedGyn Pipette | Medgyn Products, Inc. | 1 |
| WomanCare Global Single-Valve Aspirator Accessory Kit | Womancare Global Trading, Inc. | 1 |
| WomanCare Global Ipas MVA Plus® Aspirator Accessory Kit | Womancare Global Trading, Inc. | 1 |
| MedGyn Pipette II | Medgyn Products, Inc. | 1 |
| MedGyn Pipette IV | Medgyn Products, Inc. | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.