RADPAD

Basic Information

• Brand Name: RADPAD
• Primary DI: 00852814003261
• Version / Model: 5400A-O
• Company Name: WORLDWIDE INNOVATIONS & TECHNOLOGIES, INC.
• Labeler DUNS: 121621853
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-19
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 28f3ce56-d689-4146-84d9-1333e0301144

Device Description

EP Left Subclavian Shield-Orange

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KPY	Shield, protective, personnel	Radiology	892.6500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38357	Radiation shielding blanket	A personal protective device intended to shield selected body parts of a patient, or others, from unnecessary exposure to radiation during diagnostic or therapeutic medical or dental procedures. Radiation protection blankets used in diagnostic x-ray and nuclear medicine typically consist of a fluid resistant outer covering that surrounds a thin sheet of lead (Pb) or lead-equivalent material. Blankets intended to attenuate neutrons are composed of hydrogenous materials instead of lead. Blankets used in mixed beta-gamma radiation field may have layers of both hydrogenous and lead-equivalent materials.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10852814003268	GS1		15	In Commercial Distribution
Primary	00852814003261	GS1
Package	20852814003265	GS1		4	In Commercial Distribution