NCircle

NCircle, Nitinol Tipless Stone Extractor Modified Delta Wire, Basket

Registry build 21.09.26
21manufacturers in China registered for this device type
12catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (8), Guangdong (5), Zhejiang (4). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FFL
Manufacturer City Province Registered as Device types
Well Lead Medical Co., Ltd. Guangzhou Guangdong Contract manufacturer 46
Changzhou Health Microport Medical Device Co., Ltd. Changzhou Jiangsu Contract manufacturer 10
Changshu Rozer Sterilization Technology Co., Ltd. Changshu Jiangsu Contract manufacturer 43
Rozer Sterilization Technology Shuyang Company Limited Shuyang Jiangsu Contract manufacturer 33
Zhejiang Chuangxiang Medical Technology Co., Ltd. Hangzhou Zhejiang Contract manufacturer 27
Goals Sterilization Co., Ltd. Jiaxing Zhejiang Contract manufacturer 26
Yangzhou Fartley Medical Instrument Technology Co., Ltd. Yangzhou Jiangsu Contract manufacturer 24
Wuxi Goals Medical Technology Co., Ltd. Yixing Jiangsu Contract manufacturer 24
Jiana Sterilization Technology (Hangzhou) Co., Ltd. Hangzhou Zhejiang Contract manufacturer 23
Shenzhen Hugemed Medical Technical Development Co., Ltd. Shenzhen Guangdong Manufacturer 22
Jiangsu Vedkang Medical Science and Technology Co., Ltd. Changzhou Jiangsu Manufacturer 20
Guangdong Biolight Meditech Co., Ltd. Zhuhai Guangdong Manufacturer 19

Showing 12 of 21. All 21 manufacturers in China registered for Dislodger, Stone, Basket, Ureteral, Metal

Record

Regulatory record for NCircle
Listed by Cook Incorporated, United States
FDA product code FFL
Device type Dislodger, Stone, Basket, Ureteral, Metal
Device class Class 2
Regulation 21 CFR 876.4680
Establishment Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2016-09-24
Record revised 2020-11-06 (version 4)

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, manufacturing date
Storage Special storage condition: Store in dark, dry, cool place.

Catalogue Numbers

Catalogue numbers for NCircle
Catalogue number Size Status
G18778 In distribution
G17680 In distribution
G17872 In distribution
G19111 In distribution
G18193 In distribution
G19110 In distribution
G17627 In distribution
G49620 In distribution
G17520 In distribution
G46206 In distribution
G18777 In distribution
G18191 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Gemini Boston Scientific Corporation 25
V. Mueller Carefusion 2200, Inc. 23
Porges Coloplast Coloplast A/S 23
Seplou Seplou (Zhuhai) Co., Ltd. 22
Captura Cook Incorporated 18
Memory Basket Cook Incorporated 17
Cook Cook Incorporated 17
Tricep Boston Scientific Corporation 10
Segura Hemisphere Boston Scientific Corporation 9
Greenwald Surgical Company, Inc. Grace Manufacturing Inc 9
Disposable Retrieval Basket TeleMed Systems 8
HueRex™ Disposable Stone Retrieval Basket Shenzhen Hugemed Medical Technical Development Co., Ltd. 8

Showing 12 of 112. All products under Dislodger, Stone, Basket, Ureteral, Metal

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