Culdoscope (And Accessories)
UTERUS MANIPULATOR Ø 12MM WL 430MM for uterus fixation, distally angled, TL 659mm, with Luer connection, reusable
1manufacturer
5catalogue 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 | Richard Wolf Gmbh, Germany |
|---|---|
| FDA product code | HEW |
| Device type | Culdoscope (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1640 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Record published | 2016-09-26 |
| Record revised | 2024-11-21 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Hydrogen Peroxide, Ethylene Oxide, Moist Heat or Steam Sterilization |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Outer diameter 7.5 to 12 mm; length 37 to 430 mm |
| Distribution end date | 2018-11-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8370501 | Outer Diameter 12 mm | Withdrawn |
| 8983201 | Withdrawn | |
| 8370513 | Outer Diameter 10 mm | Withdrawn |
| 8370512 | Outer Diameter 7.5 mm | Withdrawn |
| 8370511 | Length 37 mm | Withdrawn |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 |
| ColpotomizOR Tube | THE O R Company PTY Ltd | 4 |
| ColpotomizOR Tube System | 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.