Steradian Shield

Basic Information

• Brand Name: Steradian Shield
• Primary DI: 00853714008080
• Version / Model: SS0200
• Catalog Number: SS0200
• Company Name: RADUX DEVICES, LLC
• Labeler DUNS: 079668796
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-02
• Public Version: 2
• Public Version Date: 2024-02-01
• Public Version Status: Update
• Public Device Record Key: f503a62b-3ae9-4125-b6ef-3f290b036db9

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
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	878.4370	2
KPT	Calibrator, Dose, Radionuclide	Radiology	892.1360	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
Package	10853714008087	GS1	inner pack	10	In Commercial Distribution
Primary	00853714008080	GS1
Package	20853714008084	GS1	Carton	5	In Commercial Distribution

Customer Contacts

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