Identity
- Trade Name
- ColpotomizOR Tube FDA UDI
- Generic Name
- Colpotomy tube FDA UDI
- Device Name
- 35mm Diameter Trans-Vaginal Tube, 3 Way Valve and Silicone Tie FDA UDI
- Model / Reference
- 35mm FDA UDI
- Description
- 35mm Diameter Trans-Vaginal Tube, 3 Way Valve and Silicone Tie FDA UDI
Identifiers
- Catalog Number
- C35-TV FDA UDI
- Primary DI / UDI-DI
- 09349967001424 FDA UDI
- FDA Product Code
- HEW FDA UDI
- GMDN Term
- Colpotomy tube FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1640 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 — 35 Millimeter FDA UDI
Category: Colpotomy tube
ColpotomizOR Tube by The O R Company Pty Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Colpotomy tube.
- ColpotomizOR Tube System — SURGI SUPPLIES INTERNATIONAL PTY. LTD. · Class II
- ColpotomizOR Tube System — SURGI SUPPLIES INTERNATIONAL PTY. LTD. · Class II
- ColpotomizOR Tube — SURGI SUPPLIES INTERNATIONAL PTY. LTD. · Class II
- ColpoWave Balloon — Surgitools Pty , Ltd. · Class II
- ColpoWave Balloon — Surgitools Pty , Ltd. · Class II
- ColpoWave Colpotomizer — Surgitools Pty , Ltd. · Class II
- ColpotomizOR Tube — SURGI SUPPLIES INTERNATIONAL PTY. LTD. · Class II
- ColpoWave Colpotomizer — Surgitools Pty , Ltd. · 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 614c3dd8-36f5-4d5a-b5e6-2fb919a92817 35 fields · synced May 30, 2026