FDA.reportPublic FDA data

Radiaxon®

Primary DI
10813172025088
Brand
Radiaxon®
Company
INNOVATIVE HEALTHCARE CORPORATION
Model
XR3565-85
Device description
Gloves, Radiation Attenuation, Polyisoprene, 6.5
Published
2022-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
IWPRadiographic Protective Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWPRadiographic Protective GloveRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20813172025078PackageGS14In Commercial Distribution
10813172025088PrimaryGS10
00813172025081Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081317202507820813172025078
1081317202508810813172025088
00813172025081008131720250818131720250810813172025081

GMDN Terms#

Term, Definition table
TermDefinition
Radiation attenuating polyisoprene surgical/procedural gloveA sterile device made of polyisoprene 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 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 comfort of use, 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.

Regulatory Flags#

DUNS number
802020693
Device count
5
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20813172021735NitriDerm® Ultra Black1870502022-12-08
20813172021742NitriDerm® Ultra Black1871002022-12-08
20813172021759NitriDerm® Ultra Black1872002022-12-08
20813172021766NitriDerm® Ultra Black1873002022-12-08
20813172021773NitriDerm® Ultra Black1873502022-12-08
20813172021780NitriDerm® Ultra Black1874002022-12-08
20813172021797NitriDerm® Ultra Black1874502022-12-08
10813172025477NitriDerm® Biodegradable1790522025-12-22
10813172025484NitriDerm® Biodegradable1791022025-12-22
10813172025491NitriDerm® Biodegradable1792022025-12-22
10813172025507NitriDerm® Biodegradable1793022025-12-22
10813172025514NitriDerm® Biodegradable1793522025-12-22
20813172025474NitriDerm® Biodegradable1790522025-12-22
20813172025481NitriDerm® Biodegradable1791022025-12-22
20813172025498NitriDerm® Biodegradable1792022025-12-22
20813172025504NitriDerm® Biodegradable1793022025-12-22
20813172025511NitriDerm® Biodegradable1793522025-12-22
10813172025422NitriDerm® 1001640502025-11-12
10813172025439NitriDerm® 1001641002025-11-12
10813172025446NitriDerm® 1001642002025-11-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860010574508APFG65F&L Medical Products LLCIWP2023-11-28
00860010574522APFG75F&L Medical Products LLCIWP2023-11-28
00860010574553APFGXLF&L Medical Products LLCIWP2023-11-28
00860010574515APFG70F&L Medical Products LLCIWP2023-11-27
00860010574539APFG80F&L Medical Products LLCIWP2023-11-27
00860010574546APFG85F&L Medical Products LLCIWP2023-11-27
G031100VRL0Vinyl Lead GlovesShielding International Inc.IWP2023-08-08
G031101MITRL0Lead MittensShielding International Inc.IWP2023-08-08
G031101SLMITRL0Lead Slit MittensShielding International Inc.IWP2023-08-08
G031104OPMRL0Open Palm MittShielding International Inc.IWP2023-08-08
G031104VMRL0Vet MittShielding International Inc.IWP2023-08-08
G031200LRL0200L - Leather Lead GlovesShielding International Inc.IWP2023-08-08
08904333246673UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246680UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246697UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246703UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246710UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246727UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246734UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246741UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246758UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246765UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246772UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246789UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246796UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246802UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246819UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246826UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246833UniRayUNIRAY MEDICAL LLPIWP2023-02-11
08904333246840UniRayUNIRAY MEDICAL LLPIWP2023-02-11