FDA.reportPublic FDA data

UniRay

Primary DI
08904333250557
Brand
UniRay
Company
UNIRAY MEDICAL LLP
Model
UFGM1301
Device description
Mittens (Full coverage) / pair, 0.5mm
Published
2023-02-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
08904333250557PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08904333250557089043332505578904333250557

GMDN Terms#

Term, Definition table
TermDefinition
Partial-hand radiation shieldA flat pad with a strap or partial glove assembly used to shield only a portion of the hand or fingers of the wearer from unnecessary exposure to primary and scattered radiation associated with diagnostic and therapeutic medical procedures. Some types can be designed to shield just the palm, others may shield only the dorsal surface of the hand and fingers. It typically consists of a fluid resistant outer covering that surrounds a thin sheet of lead (Pb) or lead-equivalent material and is typically intended to be worn over patient examination or surgical gloves.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
650843316
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08904333250601UniRayUFD3E1002023-02-18
08904333250618UniRayUFD3T1002023-02-18
08904333234021UniRayUFD42B022023-02-18
08904333234052UniRayUFD42B052023-02-18
08904333234083UniRayUFD42B032023-02-18
08904333240404UniRayUFD42B042023-02-18
08904333240497UniRayUFD42B092023-02-18
08904333240558UniRayUFD42B122023-02-18
08904333246666UniRayUFD42B012023-02-18
08904333253169UniRayUFD3E1002023-02-18
08904333253152UniRayUFD3T1002023-02-18
08904333252506UniRayDFD001002023-02-18
08904333252513UniRayDFD001012023-02-18
08904333252520UniRayDFD001022023-02-18
08904333252537UniRayDFD001032023-02-18
08904333252544UniRayDFD001042023-02-18
08904333252551UniRayDF9300022023-02-18
08904333252568UniRayDF9300032023-02-18
08904333252575UniRayDF9300082023-02-18
08904333204543UniRayUF1S12232023-02-10

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