Singular

SINGULAR Polypectomy Snare; Medium Hexagonal Loop, Firm Wire, Microvasive Connector

Registry build 21.09.26
7manufacturers in China registered for this device type
10catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (3), Zhejiang (3), Beijing (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FDI
Manufacturer City Province Registered as Device types
Zhejiang Chuangxiang Medical Technology Co., Ltd. Hangzhou Zhejiang Contract manufacturer 27
Yangzhou Fartley Medical Instrument Technology Co., Ltd. Yangzhou Jiangsu Contract manufacturer 24
Micro-Tech (Nanjing) Co., Ltd. Nan Jing Jiangsu Contract manufacturer 49
Beijing Zksk Technology Co., Ltd. Beijing Beijing Contract manufacturer 38
Jiana Sterilization Technology (Hangzhou) Co., Ltd. Hangzhou Zhejiang Contract manufacturer 23
Jiangsu Vedkang Medical Science and Technology Co., Ltd. Changzhou Jiangsu Manufacturer 20
Hangzhou AGS MedTech Co., Ltd. Hangzhou Zhejiang Repacker / relabeller 19

Record

Regulatory record for Singular
Listed by ConMed Corporation, United States
FDA product code FDI
Device type Snare, Flexible
Device class Class 2
Regulation 21 CFR 876.4300
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Record published 2016-09-24
Record revised 2022-04-12 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Ethylene Oxide
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date
Storage Storage environment temperature 50 to 90 °F; Storage environment temperature 10 to 32 °C; Handling environment temperature -20 to 140 °F; Handling environment humidity 30 to 75 % RH; Handling environment temperature 16 to 27 °C; Handling environment temperature -29 to 60 °C
Packaging Box of 10
Sizes Length 230 cm
Distribution end date 2022-04-11

Catalogue Numbers

Catalogue numbers for Singular
Catalogue number Size Per pack Status
000986 Length 230 cm 10 Withdrawn
000984 Length 230 cm 10 Withdrawn
000958 Length 230 cm 10 Withdrawn
000992 Length 230 cm 10 Withdrawn
000966 Length 230 cm 10 Withdrawn
000964 Length 230 cm 10 Withdrawn
000960 Length 230 cm 10 Withdrawn
000988 Length 230 cm 10 Withdrawn
000979 Length 230 cm 10 Withdrawn
000980 Length 230 cm 10 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Snare, Flexible Hangzhou AGS MedTech Co., Ltd. 125
Non-Rotatable Snares Zhejiang Chuangxiang Medical Technology Co., Ltd. 58
ClearGrasp Snare Finemedix 36
Zksk Beijing Zksk Technology Co., Ltd. 30
Disposable Polypectomy Snare TeleMed Systems 29
Polypectomy Snare Micro-Tech (Nanjing) Co., Ltd. 20
Roth Net Us Endoscopy 15
EdgeHog(TM) Polypectomy Snare Micro-Tech (Nanjing) Co., Ltd. 14
Halyard Avanos Medical, Inc. 11
Disposable Polyp Snare Jiangsu Vedkang Medical Science and Technology Co., Ltd. 10
Multiple Loop Polypectomy Snare Avanos Medical, Inc. 8
Optimizer ConMed Corporation 8

Showing 12 of 61. All products under Snare, Flexible

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