Trinity Sterile, Inc.

Tourn Cuff 34"X4" Disp 2P 1B

Registry build 21.09.26
124manufacturers in China registered for this device type
25catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (47), Jiangsu (26), Guangdong (16). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GAX
Manufacturer City Province Registered as Device types
Shanghai Joy Crown Industry Co., Ltd. Pu Dong New Area Shanghai Contract manufacturer 64
Zhejiang Hongyu Medical Commodity Co., Ltd. Yiwu Zhejiang Contract manufacturer 36
Jingmen Huasheng Asia Dynamics Sanitary Products Co., Ltd. Jingmen Hubei Contract manufacturer 23
Anji Hengfeng Sanitary Material Co., Ltd. Anji Zhejiang Contract manufacturer 20
Changzhou Recoo Healthcare Co., Ltd. Changzhou Jiangsu Contract manufacturer 19
Xiantao Rayxin Medical Products Co., Ltd. Xiantao Hubei Contract manufacturer 18
Hangzhou Aosi Healthcare Co., Ltd. Hangzhou Zhejiang Contract manufacturer 18
Nantong City Yojo Medical Products Co., Ltd. Haimen Jiangsu Contract manufacturer 14
Jiangsu Senolo Medical Technology Co., Ltd. Yancheng Jiangsu Contract manufacturer 12
Vistar Medical Supplies Co., Ltd. Shenzhen Guangdong Contract manufacturer 11
Wenzhou Dongfang Medical Instruments Co., Ltd. Wenzhou Zhejiang Contract manufacturer 10
Elite Medtek(Jiangsu) Co., Ltd. Changzhou Jiangsu Contract manufacturer 9

Showing 12 of 124. All 124 manufacturers in China registered for Tourniquet, Nonpneumatic

Record

Regulatory record for Trinity Sterile, Inc.
Listed by Trinity Sterile, Inc., United States
FDA product code GAX
Device type Tourniquet, Nonpneumatic
Device class Class 1
Regulation 21 CFR 878.5900
Establishment Contract manufacturer, Contract steriliser, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2023-03-24
Record revised 2023-11-06 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Ethylene Oxide
Supplied sterile Yes
Single use Yes
Label carries lot or batch number, serial number
Packaging Pack of 1000, pack of 1200, pack of 20, pack of 1500, pack of 500, pack of 2000
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Trinity Sterile, Inc.
Catalogue number Size Status
10048 In distribution
10001 In distribution
10103 In distribution
10084 In distribution
10005 In distribution
11214 In distribution
10039 In distribution
10007 In distribution
10006 In distribution
10082 In distribution
10004 In distribution
10044 In distribution
1200LG In distribution
10085 In distribution
10038 In distribution
10045 In distribution
11212 In distribution
10090 In distribution
1200SM In distribution
11207 In distribution
10050 In distribution
10086 In distribution
1200MD In distribution
10003 In distribution
1200XL In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Rhino Rescue Wuxi Emsrun Technology Co., Ltd. 55
FCP Bandage First Care Products Ltd. 39
NAR North American Rescue, LLC. 39
Bioseal Inc. Bioseal 36
Cardinal Health Cardinal Health 200, LLC 29
DeRoyal Deroyal Industries, Inc. 28
ASP Medical ASP Global, LLC 20
MedSource Tourniquet Medsource International, LLC 17
Marketlab Marketlab Incorporated 16
Medical Action Industries Medical Action Industries, Inc. 16
Novaplus ASP Global, LLC 15
MediChoice Owens & Minor Distribution, Inc. 14

Showing 12 of 171. All products under Tourniquet, Nonpneumatic

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