Porta Shield

PTSSHIELD4 (DRAPE ONLY PORTA SHIELD PTS4 36"L X 24' W RL GREY V), .5mm Regular Lead

Registry build 21.09.26
2manufacturers in China registered for this device type
4catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (1), Henan (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code EAK
Manufacturer City Province Registered as Device types
Jiangsu Jumao X-Care Medical Equipment Co., Ltd. Danyang Jiangsu Contract manufacturer 37
Zhengzhou Henghao Optical Technology Co., Ltd. Zhengzhou Henan Manufacturer 6

Record

Regulatory record for Porta Shield
Listed by Burlington Medical, LLC, United States
FDA product code EAK
Device type Screen, Leaded, Operator Radiation Protector
Device class Class 1
Regulation 21 CFR 892.6500
Establishment Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2022-09-22

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Porta Shield
Catalogue number Size Status
PTSSHIELD3 In distribution
PTSSHIELD4 In distribution
PTSSHIELD1 In distribution
PTSSHIELD2 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Aadco Aadco Medical, Inc. 101
Kenex Kenex (Electro-Medical) Ltd. 69
OT Mavig Gmbh 64
Drape Burlington Medical, LLC 7
Hercules Medium Duty Suspension System Aadco Medical, Inc. 5
Rampart Rampart IC, Inc 4
Clear Lead Barrier Biodex Medical Systems, Inc. 3
Screen, Leaded, Operator Radiation Protector Steris Corporation 2
Techno-Aide Techno-Aide, Inc. 2
Steradian Shield Radux Devices Inc 1
ExoShield Northstar Medical Radioisotopes, LLC 1
Rolling Radiation Shield Alimed, LLC 1

Showing 12 of 21. All products under Screen, Leaded, Operator Radiation Protector

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