Identity
- Trade Name
- WomanCare Global Single-Valve Aspirator FDA UDI
- Generic Name
- Abortion suction system collection bottle FDA UDI
- Device Name
- The device is used to evacuate the contents of the uterus. It consists of a 60cc syringe barrel, plunger, collar stop, o-ring, and removable valve liner. Aspirators are compatible with cannulae size 3-6mm. Aspirator is sterile, clean, and single use. FDA UDI
- Model / Reference
- SVS-S10 FDA UDI
- Description
- The device is used to evacuate the contents of the uterus. It consists of a 60cc syringe barrel, plunger, collar stop, o-ring, and removable valve liner. Aspirators are compatible with cannulae size 3-6mm. Aspirator is sterile, clean, and single use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00853615006352 FDA UDI
- FDA Product Code
- HHI FDA UDI
- GMDN Term
- Abortion suction system collection bottle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.5070 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 3.5 Inch FDA UDILength — 8.5 Inch FDA UDITotal Volume — 60 Milliliter FDA UDI
Category: Abortion suction system collection bottle
WomanCare Global Single-Valve Aspirator by Womancare Global Trading, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Abortion suction system collection bottle.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Womancare Global Trading, Inc.
Sources (1)
- FDA UDI 21a3e6d3-8db9-46c6-87f7-6bdac2b89d24 36 fields · synced May 30, 2026