Identity
- Trade Name
- HUI FDA UDI
- Generic Name
- Uterine manipulator, single-use FDA UDI
- Device Name
- HUI® Harris Uterine Injector O.D.: 4.5 mm • Length: 22.9 cm (9") • Recommended Balloon Inflation: Air 5cc FDA UDI
- Model / Reference
- 6002 FDA UDI
- Description
- HUI® Harris Uterine Injector O.D.: 4.5 mm • Length: 22.9 cm (9") • Recommended Balloon Inflation: Air 5cc FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937013191 FDA UDI
- 510(k) Number
- K770727 FDA UDI
- FDA Product Code
- KNA FDA UDI
- GMDN Term
- Uterine manipulator, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4530 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Uterine manipulator, single-use
Hui by CooperSurgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K770727 also covers:
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
- CooperSurgical, Inc.
Sources (1)
- FDA UDI 8125157b-6be8-41d6-b6d1-6fb5428ed372 34 fields · synced Jun 9, 2026