ESI

MCGIVNEY HEMORRHOIDAL LIGATOR WITH LOADING CONE, 100 RINGS AND ANGLED FORCEPS. (Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions)

Registry build 21.09.26
12manufacturers in China registered for this device type
11catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (7), Zhejiang (2), Beijing (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FHN
Manufacturer City Province Registered as Device types
Jiangsu Grit Medical Technology Co., Ltd. Changzhou Jiangsu Contract manufacturer 13
Changzhou Health Microport Medical Device Co., Ltd. Changzhou Jiangsu Contract manufacturer 10
Changzhou Tongchuang Medical Instrument Technology Co., Ltd. Changzhou Jiangsu Contract manufacturer 4
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Micro-Tech (Nanjing) Co., Ltd. Nan Jing Jiangsu Contract manufacturer 49
Beijing Zksk Technology Co., Ltd. Beijing Beijing Contract manufacturer 38
Zhejiang Chuangxiang Medical Technology Co., Ltd. Hangzhou Zhejiang Contract manufacturer 27
Alton Shanghai Medical Instruments Co Ltd Shanghai Shanghai Complaint-file establishment 20
Zhuji Pengtian Medical Instrument Co., Ltd. Zhuji Zhejiang Manufacturer 10
Jiangsu Shenli Medical Production Co., Ltd. Changzhou Jiangsu Contract manufacturer 6
LEO Medical Co., Ltd. Changzhou Jiangsu Manufacturer 4
Well Care (Wuhan) Medical Technology Co., Ltd. Wuhan Hubei Manufacturer 4

Record

Regulatory record for ESI
Listed by FTT Medical, Inc.
FDA product code FHN
Device type Ligator, Hemorrhoidal
Device class Class 2
Regulation 21 CFR 876.4400
Premarket notification Exempt
Record published 2016-09-22
Record revised 2019-09-18 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Latex Contains natural rubber latex
Label carries lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for ESI
Catalogue number Size Status
37-0810C In distribution
37-0810 In distribution
37-2830 In distribution
37-0814 In distribution
37-2820 In distribution
37-0813 In distribution
37-2824 In distribution
37-0811 In distribution
37-2822 In distribution
37-2800 In distribution
37-0812 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Surgical Direct Surgical Direct, Inc. 20
Hemorrhoids Multiple Band Ligator Set Micro-Tech (Nanjing) Co., Ltd. 16
Millennium Avalign Technologies, Inc. 15
Hayden Medical Hayden Medical Inc 12
Ligation Device LEO Medical Co., Ltd. 12
BR Surgical, LLC BR Surgical LLC 11
MT Micro-Tech (Nanjing) Co., Ltd. 10
Multiple Band Ligator Set Micro-Tech (Nanjing) Co., Ltd. 10
Surtex Surtex Instruments Ltd 8
Aesculap Aesculap AG 8
Avalign Avalign Technologies, Inc. 8
Pilling Teleflex Medical LLC 8

Showing 12 of 64. All products under Ligator, Hemorrhoidal

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