Swift Loop

Silicone elastomer Loops with Blunt Needle and pledget.

Registry build 21.09.26
9manufacturers in China registered for this device type
3catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (4), Zhejiang (4), 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 GAE
Manufacturer City Province Registered as Device types
Gcmedica Enterprise Ltd.(Wuxi) Wuxi Jiangsu Contract manufacturer 55
Ningbo Luke Medical Devices Co., Ltd. Yuyao Zhejiang Contract manufacturer 27
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Micro-Tech (Nanjing) Co., Ltd. Nan Jing Jiangsu Contract manufacturer 49
Steris Sterilization Technologies (Suzhou) Ltd Suzhou Jiangsu Contract manufacturer 44
Joykey Industrial (Pinghu) Limited Pinghu Zhejiang Contract manufacturer 43
Bothwin (Beijing) Medical Technology Co., Ltd. Beijng Beijing Manufacturer 25
Anrei Medical (Hangzhou) Co., Ltd. Hangzhou Zhejiang Manufacturer 12
Cixi Bohong Bath Appliances Co., Ltd. Ningbo Zhejiang Manufacturer 4

Record

Regulatory record for Swift Loop
Listed by Coroneo, Inc., Canada
FDA product code GAE
Device type Snare, Surgical
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Manufacturer
Premarket notification Exempt
Record published 2023-06-28

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: Keep away from sunlight.; Special storage condition: Keep dry.

Catalogue Numbers

Catalogue numbers for Swift Loop
Catalogue number Size Per pack Status
1011058 10 In distribution
1010815 10 In distribution
1010643 10 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Scanlan® Surg-I-Loop® silicone loops Scanlan International, Inc. 20
Snare, Surgical Anrei Medical(HZ) Co., Ltd. 6
Cold Snare Micro-Tech (Nanjing) Co., Ltd. 4
LesionHunter(TM) Rotatable Nitinol Cold Snare Micro-Tech (Nanjing) Co., Ltd. 3
Surgical Support Tie LivaNova USA, Inc. 3
Medline Medline Industries, Inc. 3
Scanlan® Surg-I-Loop® Plus with semi-sharp needle Scanlan International, Inc. 2
Medline Renewal Medline Industries, Inc. 2
LiNA OperaScopeTM Lasso LiNA Medical AG 2
LiNA OperaScope Angled Lasso LiNA Medical AG 2
LiNA OperaScope™ Lasso LiNA Medical AG 2
Scanlan® Surg-I-Loop® Plus with blunt needle Scanlan International, Inc. 2

Showing 12 of 32. All products under Snare, Surgical

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