Circular Stapler Anvil Sizer Set

Circular Stapler Anvil Sizer Set includes (1) 25 mm, (1) 29 mm, and (1) 33 mm reusable anvil sizers that are used to assist in choosing surgical stapler size.

Registry build 21.09.26
5manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Shanghai (1), Shandong (1), Zhejiang (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 KOA
Manufacturer City Province Registered as Device types
Principle & Will Biotech (Pinghu) Co., Ltd. Pinghu Zhejiang Contract manufacturer 39
Dongguan Shin YI Healthcare Products Factory Dong Guan Guangdong Contract manufacturer 30
Xiamen HOY Plastic Industrial Co., Ltd. Xiamen Fujian Contract manufacturer 5
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222

Record

Regulatory record for Circular Stapler Anvil Sizer Set
Listed by Tools FOR Surgery, LLC, United States
FDA product code KOA
Device type Surgical Instruments, G-U, Manual (And Accessories)
Device class Class 1
Regulation 21 CFR 876.4730
Establishment Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2023-07-19

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Circular Stapler Anvil Sizer Set
Catalogue number Size Status
ANS-10 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Elmed Elmed, Inc. 233
Millennium Avalign Technologies, Inc. 64
Elmed Incorporated Elmed, Inc. 58
Ambler Surgical Ambler Surgical, LLC 35
Greenwald Surgical Company, Inc. Grace Manufacturing Inc 33
Cardinal Health Cardinal Health 200, LLC 30
Novo Surgical Novo Surgical, Inc. 29
Novo Surgical Inc. Novo Surgical, Inc. 23
LHB Industries The Lighthouse For the Blind, Inc. 15
Zoll-Dental Zoll-Dental 13
Gyrus Acmi Gyrus Acmi, Inc. 13
Cook Cook Incorporated 8

Showing 12 of 74. All products under Surgical Instruments, G-U, Manual (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