Tri-Staple 2.0

Black Extra Thick Circular Reload For use with Signia Circular Adapters

Registry build 21.09.26
16manufacturers in China registered for this device type
3catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (8), Zhejiang (3), Shanghai (3). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code GAG
Manufacturer City Province Registered as Device types
Jiangsu Saikang Medical Equipment Co., Ltd. Zhangjiagang Jiangsu Contract manufacturer 34
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Zhejiang Mediunion Healthcare Group Co., Ltd. Ningbo Zhejiang Contract manufacturer 105
Nanjing J SUN Healthcare Co., Ltd. Nanjing Jiangsu Repacker / relabeller 56
Jiangsu WLD Medical Co., Ltd. Yizheng Jiangsu Contract manufacturer 50
Jiangsu Yongfa Medical Equipment Technology Co., Ltd. Zhangjiagang Jiangsu Manufacturer 33
Tonglu Wanhe Medical Instrument Co., Ltd. Hangzhou Zhejiang Manufacturer 24
Zhangjiagang Municipal Cnnc Huakang Radiation Co., Ltd. Zhangjiagang Jiangsu Contract manufacturer 17
Changzhou Lookmed Medical Instrument Co., Ltd. Changzhou Jiangsu Manufacturer 8
B.j.zh.f.panther Medical Equipment Co., Ltd. Beijing Beijing Manufacturer 6
Touchstone International Medical Science Co., Ltd. Suzhou Jiangsu Manufacturer 5
Victor Medical Instruments Co., Ltd. Changzhou Jiangsu Manufacturer 5

Showing 12 of 16. All 16 manufacturers in China registered for Stapler, Surgical

Record

Regulatory record for Tri-Staple 2.0
Listed by Covidien LP, United States
FDA product code GAG
Device type Stapler, Surgical
Device class Class 2
Regulation 21 CFR 878.4740
510(k) K221629
Record published 2024-11-29
Record revised 2026-08-03 (version 6)

Specifications

Specifications
MRI safety MR Conditional
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number
Storage Storage environment atmospheric pressure 55 to 101 KiloPascal; Storage environment humidity up to 90 % RH; Storage environment temperature 63 to 94 °F
Packaging Pack_or_inner_pack of 6
Sizes Outer diameter 28 to 33 cm

Catalogue Numbers

Catalogue numbers for Tri-Staple 2.0
Catalogue number Size Status
SIGCIR31XT Outer Diameter 31 cm In distribution
SIGCIR28XT Outer Diameter 28 cm In distribution
SIGCIR33XT Outer Diameter 33 cm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
McKesson Mckesson Medical-Surgical Inc. 23
Medline Industries, Inc. Medline Industries, Inc. 12
EEA Covidien LP 8
DeRoyal Deroyal Industries, Inc. 7
Aeon Lexington Medical, Inc. 6
Echelon Ethicon Endo-Surgery, Inc. 6
easyEndoTM Lite Linear Cutting Stapler for Single Use Ezisurg Medical Co., Ltd. 6
Echelon Linear Cutter Ethicon Endo-Surgery, Inc. 5
Henry Schein Henry Schein, Inc. 4
Ethicon Ethicon Endo-Surgery, Inc. 3
GIA Covidien LP 3
Medline Medline Industries, Inc. 2

Showing 12 of 21. All products under Stapler, 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