ColpotomizOR Tube System
4 catalogue numbers from CTS45-TV, listed by THE O R Company PTY Ltd, Australia, under Culdoscope (And Accessories). 1 manufacturer in China is registered for this product code.
1manufacturer
4catalogue numbers in this listing
Who Else Makes It
Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Tonglu Qianyan Medtech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
Record
| Listed by | THE O R Company PTY Ltd, Australia |
|---|---|
| FDA product code | HEW |
| Device type | Culdoscope (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1640 |
| Establishment | Specification developer, Private-label distributor, Manufacturer, Exporter |
| Record published | 2019-03-27 |
| Record revised | 2026-04-21 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Shipper of 3, outer of 5 |
| Sizes | Outer diameter 32 to 45 mm |
| Distribution end date | 2026-04-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CTS45-TV | Outer Diameter 45 mm | In distribution |
| CTS35-TV | Outer Diameter 35 mm | In distribution |
| CTS45-TV | Outer Diameter 32 mm | Withdrawn |
| CTS35-TV | Outer Diameter 32 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| GelPOINT V-Path | Applied Medical Resources Corp. | 8 |
| Rumi II Koh-Efficient | Coopersurgical, Inc. | 8 |
| Arch Koh-Efficient | Coopersurgical, Inc. | 8 |
| Culdoscope (And Accessories) | Richard Wolf Gmbh | 5 |
| ColpotomizOR Tube | THE O R Company PTY Ltd | 4 |
| Advincula Delineator™ Uterine Manipulator with 3.5 cm Ultem® Koh-Efficient® | Coopersurgical, Inc. | 4 |
| Advincula Delineator Uterine Manipulator | Coopersurgical, Inc. | 4 |
| Koh Cup | Coopersurgical, Inc. | 3 |
| Ultem Koh Cup | Coopersurgical, Inc. | 3 |
| LiNA McCartney Tube | THE O R Company PTY Ltd | 2 |
| ColpotomizOR Tube | Surgi Supplies International PTY. Ltd. | 2 |
| Advincula Delineator™ Uterine Manipulator with 4.0 cm Ultem® Koh-Efficient® | Coopersurgical, Inc. | 2 |
Showing 12 of 24. All products under Culdoscope (And Accessories)
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.