Ultimate Dilating Tip Trocar With Smooth Cannula Plus Extra Cannula

5 catalogue numbers from PS4461ULT, listed by Purple Surgical International Limited, United Kingdom, under Laparoscope, Gynecologic (And Accessories). 7 manufacturers in China are registered for this product code.

Registry build 21.09.26
7manufacturers in China registered for this device type
5catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (3), Guangdong (3), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code HET
Manufacturer City Province Registered as Device types
Modern Medical Equipment Manufacturing Ltd. Heng Li, Dongguan Guangdong Contract manufacturer 26
Hangzhou Fushan Medical Appliance Co., Ltd. Hangzhou Zhejiang Contract manufacturer 44
Modern Medical Equipment Manufacturing (Qing Yuan) Ltd Qing Yuan Guangdong Contract manufacturer 26
Scivita Medical Technology Co., Ltd. Suzhou Jiangsu Manufacturer 19
Global Medical Production Co., Ltd. Jiaxing Zhejiang Manufacturer 10
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. Cixi Zhejiang Manufacturer 8
Guangdong Optomedic Technologies, Inc. Foshan Guangdong Manufacturer 7

Record

Regulatory record for Ultimate Dilating tip trocar with smooth cannula plus extra cannula
Listed by Purple Surgical International Limited, United Kingdom
FDA product code HET
Device type Laparoscope, Gynecologic (And Accessories)
Device class Class 2
Regulation 21 CFR 884.1720
Establishment Specification developer, Repacker / relabeller, Manufacturer
Record published 2016-09-17
Record revised 2020-01-09 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date
Packaging Inner box of 5, shipping carton of 20, pack of 20

Catalogue Numbers

Catalogue numbers for Ultimate Dilating tip trocar with smooth cannula plus extra cannula
Catalogue number Size Status
PS4461ULT 12mm diameter x 100mm length In distribution
PS4460ULT 10mm diameter x 100mm length In distribution
PS4462ULT 12mm diameter x 100mm length In distribution
PS4465ULT 5mm diameter x 100mm length In distribution
PS4464ULT 10mm diameter x 100mm length In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Endoplus Endoplus 448
Integra® MicroFrance® Integra Microfrance SAS 273
Symmetry Surgical® Aspen Surgical Products, Inc. 139
Laparoscope, Gynecologic (And Accessories) Karl Storz GmbH & Co. KG 119
Elmed Elmed, Inc. 96
Olympus Olympus Winter & IBE Gmbh 71
Core Dynamics ConMed Corporation 52
Symmetry Aspen Surgical Products, Inc. 48
DANmed Dannoritzer Medizintechnik GmbH & Co. KG 45
Laparoscope, Gynecologic (And Accessories) Richard Wolf Gmbh 37
Take-Apart Karl Storz GmbH & Co. KG 31
Blueendo Trokamed Gmbh 28

Showing 12 of 396. All products under Laparoscope, Gynecologic (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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer