Identity
- Trade Name
- WomanCare Global Uterine Evacuation Kit FDA UDI
- Generic Name
- Abortion suction system manual aspirator FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- UEK-SU FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00853615006307 FDA UDI
- FDA Product Code
- HHI FDA UDI
- GMDN Term
- Abortion suction system manual aspirator 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
Yes
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
Yes
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
Category: Intrauterine curette, suctionFixed-diameter cervical dilator, single-useAbortion suction system manual aspirator
WomanCare Global Uterine Evacuation Kit by Womancare Global Trading, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fixed-diameter cervical dilator, single-use.
- Gynex — GYNEX CORPORATION · Class I
- Bioseal Inc. — BIOSEAL · Class I
- Instrapac — ROBINSON HEALTHCARE LIMITED · Class I
- Gynex — GYNEX CORPORATION · Class I
- Centurion — Centurion Medical Products · Class II
- Centurion — Centurion Medical Products · Class II
- Bioseal Inc. — BIOSEAL · Class I
- Centurion — Centurion Medical Products · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Womancare Global Trading, Inc.
Sources (1)
- FDA UDI e3046d4b-11ea-4940-8c91-3406a6b3a07f 36 fields · synced May 30, 2026