Identity
- Trade Name
- Uterine Manipulator FDA UDI
- Generic Name
- Uterine injector FDA UDI
- Device Name
- K-UMI Manipulator FDA UDI
- Model / Reference
- K-UMI Manipulator FDA UDI
- Description
- K-UMI Manipulator FDA UDI
Identifiers
- Catalog Number
- TMI6003 FDA UDI
- Primary DI / UDI-DI
- M803TMI6003 FDA UDI
- FDA Product Code
- LKF FDA UDI
- GMDN Term
- Uterine injector 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
Yes
FDA UDI
MR Safe FDA UDI
Category: Uterine injector
Uterine Manipulator by Medgyn Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Medgyn Products, Inc.
Sources (1)
- FDA UDI 30656e64-b484-477a-9efd-2739061bdc69 34 fields · synced May 30, 2026