Radiaxon®

Basic Information

• Brand Name: Radiaxon®
• Primary DI: 10813172025149
• Version / Model: XR496000
• Company Name: INNOVATIVE HEALTHCARE CORPORATION
• Labeler DUNS: 802020693
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2022-12-08
• Public Version: 1
• Public Version Date: 2022-12-16
• Public Version Status: New
• Public Device Record Key: 7319e62a-220d-4861-88da-4ad2eda36b08

Device Description

Gloves, Radiation Attenuation, Latex, 6.0

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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: 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
IWP	Radiographic Protective Glove	Radiology	892.6500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
59061	Radiation attenuating Hevea-latex surgical/procedural glove	A sterile device made of Hevea natural rubber latex (NRL) intended as a protective barrier when worn on the hands of healthcare providers at the surgical/procedural site; its inner surface is not powdered and the glove's material matrix contains radiation attenuating material intended to limit wearer exposure to incident radiation (e.g., during fluoroscopy). It is used mainly as a two-way barrier to protect patient and staff from contaminants. It will have appropriate characteristics regarding tactility, and should provide appropriate physical properties (e.g., tensile strength, elasticity) and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20813172025139	GS1	5PR/4BX	4	In Commercial Distribution
Primary	10813172025149	GS1
Unit of Use	00813172025142	GS1