FDA.reportPublic FDA data

UniRay

Primary DI
08904333218212
Brand
UniRay
Company
UNIRAY MEDICAL LLP
Model
UF1S3212
Device description
Surgical apron - 0.35mm LiteLead - Medium
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
IWOApron, Protective

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWOApron, ProtectiveRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08904333218212PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08904333218212089043332182128904333218212

GMDN Terms#

Term, Definition table
TermDefinition
Radiation shielding apronA full or half-length apron-like garment intended to shield portions of the body of an individual (i.e., a device operator, patient, or other attending person) from exposure to radiation during medical or dental procedures. Some include attached or detachable collars for neck and thyroid protection. The device typically consists of a fluid resistant outer covering surrounding a thin sheet of lead (Pb) or lead-equivalent material. Those used for neutron attenuation are composed of hydrogenous materials; those used in mixed beta-gamma radiation field may have layers of both hydrogenous and lead-equivalent materials. This is a reusable device.

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
G031VBO2XFNL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XFRL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XFRLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XFTL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XFTLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XMNL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XMNLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XMRL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XMRLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XMTL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XMTLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLFNL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLFNLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLFRL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLFRLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLFTL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLFTLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLMNL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLMNLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLMRL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLMRLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLMTL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLMTLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOMFNL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOMFNLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOMFRL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOMFRLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOMFTL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOMFTLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOMMNL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13