RADPAD

Basic Information

• Brand Name: RADPAD
• Primary DI: 00852814003889
• Version / Model: 7310A-R
• Company Name: WORLDWIDE INNOVATIONS & TECHNOLOGIES, INC.
• Labeler DUNS: 121621853
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-17
• Public Version: 2
• Public Version Date: 2022-02-21
• Public Version Status: Update
• Public Device Record Key: 238696e5-922c-46a5-8b36-5fb9029b3663

Device Description

Simons Biventricular Drape Left Side - Red

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
IWQ	Curtain, protective, radiographic	Radiology	892.6500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64134	Patient radiation shielding pad/drape, single-use	A protective device intended to be placed on/draped over part of a patient’s body during a diagnostic or therapeutic radiological procedure to shield specific patient anatomies from unnecessary exposure to radiation and/or help block scatter radiation from the patient to protect healthcare workers. It commonly consists of a fluid-resistant outer covering that surrounds a thin sheet of lead (Pb) or lead-equivalent material; it is not a piece of clothing such as an apron. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00852814003889	GS1
Package	10852814003886	GS1		12	In Commercial Distribution