Gems

Gems C-arm Equipment Covers Clear Polyethylene Sterile Fits OEC 9600/9800, Siemens ARCADIS Avantic, Sieme 20 per Case

Registry build 21.09.26
107manufacturers in China registered for this device type
12catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (28), Guangdong (17), Hubei (14). 43 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code PUI
Manufacturer City Province Registered as Device types
Allmed Medical Products Co., Ltd. Zhijiang Hubei Contract manufacturer 43
Principle & Will Biotech (Pinghu) Co., Ltd. Pinghu Zhejiang Contract manufacturer 39
BH Medical Products Co., Ltd. Changzhou Jiangsu Contract manufacturer 37
Henan Yadu Industrial Co., Ltd. Changyuan Henan Contract manufacturer 35
Jiangsu JianYu Health Medical Co., Ltd. Changzhou Jiangsu Contract manufacturer 35
Jiangsu Guangda Medical Material Group Co., Ltd. Haian Jiangsu Contract manufacturer 32
Yadu Medical (Henan) Co., Ltd. Changyuan Henan Contract manufacturer 30
Jingmen Huasheng Asia Dynamics Sanitary Products Co., Ltd. Jingmen Hubei Contract manufacturer 23
Suzhou Jinsheng Plastic Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
Sino Protection (Hefei) Medical Products Co., Ltd. Hefei Anhui Contract manufacturer 18
Exact Medical Manufacturing, Inc. Changzhou Jiangsu Contract manufacturer 17
Jiangsu Likang Medical Products Co., Ltd. Wujiang Jiangsu Contract manufacturer 17

Showing 12 of 107. All 107 manufacturers in China registered for Drape, Surgical, Exempt

Record

Regulatory record for Gems
Listed by Tidi Products, LLC, United States
FDA product code PUI
Device type Drape, Surgical, Exempt
Device class Class 2
Regulation 21 CFR 878.4370
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2022-09-24
Record revised 2024-09-11 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Over the counter Yes
Latex Labelled latex-free
Label carries lot or batch number, expiry date
Packaging Case of 20, case of 12, case of 25
Distribution end date 2023-11-30

Catalogue Numbers

Catalogue numbers for Gems
Catalogue number Size Status
20866F In distribution
22152 In distribution
30351 In distribution
20475 In distribution
30352 In distribution
30802 In distribution
30729 In distribution
20862F In distribution
20493 In distribution
30353 In distribution
30728 In distribution
30727 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Convertors Cardinal Health 200, LLC 1,573
Halyard O&M Halyard, Inc. 826
Medline-Microtek Microtek Medical LLC 512
Alleset GRI Medical & Electronic Technology Co., Ltd. 493
Invenio GRI Medical & Electronic Technology Co., Ltd. 434
Medline Medline Industries, Inc. 368
Cardinal Health Cardinal Health 200, LLC 241
Beaver Visitec Inter GRI Medical & Electronic Technology Co., Ltd. 179
Steri-Drape™ 3M Company 177
Halyard Owens & Minor Distribution, Inc. 136
Microtek Microtek Medical LLC 101
Medline Industries, Inc. Medline Industries, Inc. 87

Showing 12 of 305. All products under Drape, Surgical, Exempt

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