Identity
- Trade Name
- Uterine ElevatOR Pro FDA UDI
- Generic Name
- Uterine manipulator, single-use FDA UDI
- Model / Reference
- UE-TVPRO-40 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09349967002841 FDA UDI
- FDA Product Code
- LKF 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
Dimensions & Sizes
- Size
- Outer Diameter — 40 Millimeter FDA UDI
Category: Uterine manipulator, single-use
Uterine ElevatOR Pro by The O R Company Pty Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Uterine manipulator, single-use.
- Bioteque Taiwan Ltd. — Bioteque Taiwan Ltd. · Class II
- ColpotomizOR Tube System — SURGI SUPPLIES INTERNATIONAL PTY. LTD. · Class II
- CerviGrip Uterine Manipulator — Surgitools Pty , Ltd. · Class II
- ColpotomizOR Tube System — SURGI SUPPLIES INTERNATIONAL PTY. LTD. · Class II
- blueendo — TROKAMED GmbH · Class II
- Bioteque Taiwan Ltd. — Bioteque Taiwan Ltd. · Class II
- Advincula Delineator Uterine Manipulator — CooperSurgical, Inc. · Class II
- McCarus-Volker FORNISEE® SYSTEM — LSI Solutions, Inc. · 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
- The O R Company Pty Ltd
Sources (1)
- FDA UDI b5b9fa7c-8e98-49b9-899f-6bc683bb0c42 33 fields · synced May 30, 2026