RADPAD

Basic Information

• Brand Name: RADPAD
• Primary DI: 00852814003803
• Version / Model: 5511A-Y-Bulk NS
• 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: c1197e93-4999-42ef-b11a-60597c99f110

Device Description

Fenestrated Radial Shield-Bulk Non-Sterile-Yellow

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: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

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
Primary	00852814003803	GS1