Steradian Shield

Basic Information

• Brand Name: Steradian Shield
• Primary DI: 00853714008103
• Version / Model: SS0300
• Catalog Number: SS0300
• Company Name: RADUX DEVICES, LLC
• Labeler DUNS: 079668796
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-16
• Public Version: 1
• Public Version Date: 2025-07-24
• Public Version Status: New
• Public Device Record Key: abfa7573-4d75-4355-b307-e9b252b0dfa8

Device Description

Radiation Protection Shield

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• 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
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	878.4370	2

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	00853714008103	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]