Identity
- Trade Name
- Kronner Manipujector FDA UDI
- Generic Name
- Uterine manipulator, single-use FDA UDI
- Device Name
- Uterine manipulator FDA UDI
- Model / Reference
- 6003 FDA UDI
- Description
- Uterine manipulator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937015805 FDA UDI
- 510(k) Number
- K904473 FDA UDI
- FDA Product Code
- HES FDA UDI
- GMDN Term
- Uterine manipulator, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1300 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
Dimensions & Sizes
- Size
- Outer Diameter — 5 Millimeter FDA UDILength — 33 Centimeter FDA UDI
Category: Uterine manipulator, single-use
Kronner Manipujector by CooperSurgical, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- CooperSurgical, Inc.
Sources (2)
- FDA UDI 894bd4ac-5171-4b7c-9813-bab6e4504e6b 35 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 14, 2026