OT

OT - Radiation Protective Shields, Upper Body (including Portegra)

Registry build 21.09.26
2manufacturers in China registered for this device type
64catalogue 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 OT
Listed by Mavig Gmbh, Germany
FDA product code EAK
Device type Screen, Leaded, Operator Radiation Protector
Device class Class 1
Regulation 21 CFR 892.6500
Establishment Contract manufacturer, Private-label distributor, Manufacturer, Exporter
Premarket notification Exempt
Record published 2023-07-11

Specifications

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

Catalogue Numbers

Catalogue numbers for OT
Catalogue number Size Status
OT94001I-SI In distribution
OT510025 In distribution
OT50001V60FA In distribution
OT94001I-GE In distribution
OT50003-US In distribution
OT54001IV50FA-SI In distribution
OT80002-DR In distribution
OT50001V50FA-SI In distribution
OT54001IFA In distribution
OT94001-SI In distribution
OT50002 In distribution
OT50001IFA In distribution
OT50001FA-ST In distribution
PTZTS2005OT81 In distribution
OT50001FA In distribution
OT50001V60 In distribution
OT50001-GE In distribution
OT90003 In distribution
OT50002-US In distribution
OT50001 In distribution
OT54001-MQ In distribution
OT90001 In distribution
OT50001-DR In distribution
OT94001-GE In distribution
OT50001-MQ In distribution
OT81001 In distribution
OT50001-SI In distribution
OT54001-DR In distribution
OT80002-PB In distribution
OT54001I-DR In distribution
OT80002 In distribution
OT54001FA In distribution
OT80002FA In distribution
OT50001I-MQ In distribution
OT90001V60 In distribution
OT90002 In distribution
OT90001-SI In distribution
PTZTS2002OT81 In distribution
OT90001I-SI In distribution
OT50003 In distribution
OT540034 In distribution
OT54001I-GE In distribution
OT50001I In distribution
OT50003FA In distribution
OT50011 In distribution
E-OT54B01V50S In distribution
OT50001-PH In distribution
OT80003 In distribution
OT91001 In distribution
OT500089 In distribution
OT94001#01 In distribution
OT54001-GE In distribution
OT50001-US In distribution
OT54001I-MQ In distribution
OT54001l#01 In distribution
OT58001 In distribution
OT54001#01 In distribution
OT50001IV50FA-SI In distribution
OT550029 In distribution
OT54001V50FA-SI In distribution
OT50011-DR In distribution
OT94001I#01 In distribution
OT0294-EMC In distribution
OT80001 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
Drape Burlington Medical, LLC 7
Hercules Medium Duty Suspension System Aadco Medical, Inc. 5
Porta Shield Burlington Medical, LLC 4
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