ProneView

PRONEVIEW ADJUSTABLE PROTECTIVE HELMET AND MIRROR SYS Kit

Registry build 21.09.26
66manufacturers in China registered for this device type
23catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (18), Zhejiang (16), Guangdong (11). 17 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code CCX
Manufacturer City Province Registered as Device types
Ningbo Ningyuan Import & Export Co., Ltd. Ningbo Zhejiang Contract manufacturer 80
Suzhou Meccan Import and Export Corp. Suzhou Jiangsu Contract manufacturer 71
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Lingxian Dongsheng Textile Co., Ltd. Dezhou Shandong Contract manufacturer 23
Jinhua Ivy Home Textile Co., Limited Jinhua Zhejiang Contract manufacturer 18
Shenzhen Zhouyang Medical Care Product Co., Ltd. Shenzhen Guangdong Contract manufacturer 18
Metacare Industrial Ltd Guangzhou Guangdong Contract manufacturer 17
Jiangsu Classic NEW-Type Medical Products Co., Ltd. Yancheng Jiangsu Contract manufacturer 13
Kunshan Jiehong Nonwoven Product Co., Ltd. Kunshan Jiangsu Contract manufacturer 12
Ambu Limited Xiang Yu F.T.Z., Xiamen Fujian Contract manufacturer 11
Anhui Ivymed Medical Products Co., Ltd. Xuancheng Anhui Contract manufacturer 10
Suzhou Baili Medical Supplies Co., Ltd. Suzhou Jiangsu Contract manufacturer 9

Showing 12 of 66. All 66 manufacturers in China registered for Support, Patient Position

Record

Regulatory record for ProneView
Listed by Dupaco, Inc., United States
FDA product code CCX
Device type Support, Patient Position
Device class Class 1
Regulation 21 CFR 868.6820
Establishment Contract manufacturer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2020-10-30
Record revised 2020-12-02 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date
Storage Storage environment temperature 40 to 80 °F

Catalogue Numbers

Catalogue numbers for ProneView
Catalogue number Size Per pack Status
D28630 5 In distribution
D28507CE 10 In distribution
D28590CE In distribution
D28590DE In distribution
D28600 5 In distribution
D28501CE In distribution
D29720 6 In distribution
A28732 In distribution
D28505CE 10 In distribution
D28701 5 In distribution
D28655 10 In distribution
D28700CE In distribution
D28580CE In distribution
D28502CE In distribution
D28503CE 10 In distribution
D28520CE In distribution
D28705CE In distribution
D28503CE-60 60 In distribution
D28510CE In distribution
D28706 5 In distribution
D28520DE In distribution
D28707 10 In distribution
D28621 10 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
DeRoyal Deroyal Industries, Inc. 225
Soule Medical Soule Co., THE 212
Coulmed Coulmed Products Group LLC 135
Techno-Aide Techno-Aide, Inc. 108
BoneFoam Bone Foam Inc. 93
Halyard Owens & Minor Distribution, Inc. 80
Devon Cardinal Health 75
Domico Med-Device Domico Med-Device, LLC 69
Universal Lateral Positioner® Innovative Medical Products, Inc. 69
Lateral Patient Positioning System Alphatec Spine, Inc. 65
Cardinal Health Cardinal Health 200, LLC 64
Pediatric Patient Positioner Alphatec Spine, Inc. 55

Showing 12 of 1,485. All products under Support, Patient Position

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