PremierPro

Fiberglass Padded Safety Splint, 3" x 35" Pre-Cut Splint 15pc

Registry build 21.09.26
81manufacturers in China registered for this device type
31catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (26), Jiangsu (19), Shanghai (10). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code ITG
Manufacturer City Province Registered as Device types
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Shanghai Joy Crown Industry Co., Ltd. Pu Dong New Area Shanghai Contract manufacturer 64
Principle & Will Biotech (Pinghu) Co., Ltd. Pinghu Zhejiang Contract manufacturer 39
Beijing Jinwei Kangda Medical Instrument Ltd. Langfang Hebei Contract manufacturer 21
Anji Hengfeng Sanitary Material Co., Ltd. Anji Zhejiang Contract manufacturer 20
Derma Sciences Nantong Incorporation Development Jiangsu Contract manufacturer 19
Xiantao Rayxin Medical Products Co., Ltd. Xiantao Hubei Contract manufacturer 18
Jianerkang Medical Co., Ltd. Changzhou Jiangsu Contract manufacturer 18
Kingstar Medical (Xianning) Co., Ltd. Xianning Hubei Contract manufacturer 17
Suzhou Avon Textile Co., Ltd. Suzhou Jiangsu Contract manufacturer 12
Anhui Ivymed Medical Products Co., Ltd. Xuancheng Anhui Contract manufacturer 10
Suzhou Dukangning Medical Products Co., Ltd. Suzhou Jiangsu Contract manufacturer 9

Showing 12 of 81. All 81 manufacturers in China registered for Bandage, Cast

Record

Regulatory record for PremierPro
Listed by Prestige Ameritech, United States
FDA product code ITG
Device type Bandage, Cast
Device class Class 1
Regulation 21 CFR 890.3025
Establishment Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2020-08-29
Record revised 2026-03-23 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Latex Labelled latex-free
Label carries lot or batch number, expiry date
Storage Special storage condition: Keep Dry
Packaging Case of 6

Catalogue Numbers

Catalogue numbers for PremierPro
Catalogue number Size Status
7002 In distribution
7052 In distribution
7013 In distribution
7012 In distribution
7033B In distribution
7035B In distribution
7043 In distribution
7046 In distribution
7056 In distribution
7032R In distribution
7033W In distribution
7032W In distribution
7034W In distribution
7034B In distribution
7004 In distribution
7032B In distribution
7003 In distribution
7041 In distribution
7040 In distribution
7035W In distribution
7014 In distribution
7045 In distribution
7053 In distribution
7042 In distribution
7031W In distribution
7044 In distribution
7033R In distribution
7054 In distribution
7035R In distribution
7034R In distribution
7015 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
3M™ Scotchcast™ Solventum US LLC 58
Bandage, Cast Tetra Medical Supply Corp. 55
Tex-Care Medical Flynt Amtex, Inc. 45
DeRoyal Deroyal Industries, Inc. 35
McKesson Mckesson Medical-Surgical Inc. 34
Emsrun Wuxi Emsrun Technology Co., Ltd. 25
TCC-EZ® Acell, Inc. 24
Woodcast Dassiet Oy 15
Curity Cardinal Health 14
Cardinal Health Cardinal Health 200, LLC 13
Senolo Jiangsu Senolo Medical Technology Co., Ltd. 13
Webril Cardinal Health 200, LLC 12

Showing 12 of 66. All products under Bandage, Cast

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