Elite

Elite Hipstruments System Sterilization Tray

Registry build 21.09.26
38manufacturers in China registered for this device type
2catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (9), Guangdong (9), Shanghai (5). 17 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FRG
Manufacturer City Province Registered as Device types
Tribest Dental Products Co Ltd Yangzhong Jiangsu Contract manufacturer 58
Hubei Qianjiang Kingphar Medical Material Co., Ltd. Qianjiang Hubei Contract manufacturer 52
Principle & Will Biotech (Pinghu) Co., Ltd. Pinghu Zhejiang Contract manufacturer 39
Dongguan Shin YI Healthcare Products Factory Dong Guan Guangdong Contract manufacturer 30
Anhui Ares Medical Technology Co., Ltd. Tianchang Anhui Contract manufacturer 28
Wuhan Zonsen Medical Products Co., Ltd. Wuhan Hubei Contract manufacturer 24
Sino Protection (Hefei) Medical Products Co., Ltd. Hefei Anhui Contract manufacturer 18
Exact Medical Manufacturing, Inc. Changzhou Jiangsu Contract manufacturer 17
Lianyungang Bronson Non-woven Products Co., Ltd. Lianyungang Jiangsu Contract manufacturer 16
Foshan Nanhai Plus Medical Co Ltd Foshan Guangdong Contract manufacturer 12
Primed Liyang Medical Products Manufacturing Co., Ltd. Liyang Jiangsu Contract manufacturer 11
Binzhou Dingyue Clothing Company Limited Binzhou Shandong Contract manufacturer 7

Showing 12 of 38. All 38 manufacturers in China registered for Wrap, Sterilization

Record

Regulatory record for Elite
Listed by Smith & Nephew, Inc., United States
FDA product code FRG
Device type Wrap, Sterilization
Device class Class 2
Regulation 21 CFR 880.6850
Establishment Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Record published 2015-08-29
Record revised 2023-09-07 (version 11)

Specifications

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

Catalogue Numbers

Catalogue numbers for Elite
Catalogue number Size Status
72200808 In distribution
72200808D In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Medline Medline Industries, Inc. 824
Cardinal Health Cardinal Health 200, LLC 333
Arjo Wiggins Medical, Inc. Sterimed, Inc. 286
Halyard O&M Halyard, Inc. 191
Primed Primed Medical Products Inc. 154
Brasseler USA Peter Brasseler Holdings, LLC 148
Vivit Supply Vivit Supply LLC 103
Case Medical Case Medical, Inc. 103
Gemini Medline Industries, Inc. 89
CareGUARD Care Essentials PTY Ltd 72
Halyard Owens & Minor Distribution, Inc. 70
Wrap, Sterilization Steris Corporation 69

Showing 12 of 232. All products under Wrap, Sterilization

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