FDA.reportPublic FDA data

RADPAD

Primary DI
00850013127108
Brand
RADPAD
Company
WORLDWIDE INNOVATIONS & TECHNOLOGIES, INC.
Model
5110A-B
Device description
Peripheral Shield-Blue
Published
2020-07-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KPYShield, protective, personnel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPYShield, Protective, PersonnelRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850013127105PackageGS115In Commercial Distribution
00850013127108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001312710510850013127105
00850013127108008500131271088500131271080850013127108

GMDN Terms#

Term, Definition table
TermDefinition
Patient radiation shielding pad/drape, single-useA 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.

Regulatory Flags#

DUNS number
121621853
Device count
1
DM exempt
true
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852814003209RADPAD7200A-Y2016-10-25
00852814003490RADPAD7200A-R2016-10-25
00852814003186RADPAD7100A-Y2016-10-25
00852814003223RADPAD7400-Y2016-10-25
00852814003285RADPAD7200A-O2016-10-25
00852814003353RADPAD7400-O2016-10-25
00852814003520RADPAD7400-R2016-10-25
00852814003612RADPAD7100A-O2016-10-25
00852814003629RADPAD7300A-O2016-10-25
00852814003636RADPAD7300A-Y2016-10-25
00852814003643RADPAD7310A-O2016-10-25
00852814003650RADPAD7330A-O/Y2016-10-25
00852814003667RADPAD7102A-Y2016-10-25
00852814003872RADPAD7100A-R2020-07-17
00852814003865RADPAD7300A-R2020-07-17
00852814003889RADPAD7310A-R2020-07-17
00852814003896RADPAD7301A-O2020-07-16
00852814003339RADPAD5700-O-NS2017-01-19
00852814003568RADPAD9911-Y2020-07-16
00852814003582RADPAD9912-O2020-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850061871213IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.KPY2026-02-24
00850061871220IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.KPY2026-02-24
00850061871237IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.KPY2026-02-24
00850061871459IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.KPY2026-02-24
20748426261936Medline-MicrotekMicrotek Medical LLCKPY2026-01-28
20748426261950Medline-MicrotekMicrotek Medical LLCKPY2026-01-28
00748426261901Medline-MicrotekMicrotek Medical LLCKPY2026-01-28
00748426261925Medline-MicrotekMicrotek Medical LLCKPY2026-01-28
10748426143525Medline-MicrotekMicrotek Medical LLCKPY2025-10-10
10748426143532Medline-MicrotekMicrotek Medical LLCKPY2025-10-10
00748426143504Medline-MicrotekMicrotek Medical LLCKPY2025-10-10
00748426143511Medline-MicrotekMicrotek Medical LLCKPY2025-10-10
00748426143542Medline-MicrotekMicrotek Medical LLCKPY2025-10-10
00748426143559Medline-MicrotekMicrotek Medical LLCKPY2025-10-10
10748426143099Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
10748426143426Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
10748426143433Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
10748426143457Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
10748426143495Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
00748426143061Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
00748426143412Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
00748426143481Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
00748426144280Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
00748426143078Medline-MicrotekMicrotek Medical LLCKPY2025-09-25
00748426143467DRAPE ARMOUR™Microtek Medical LLCKPY2025-09-25
10748426143471DRAPE ARMOUR™Microtek Medical LLCKPY2025-09-23
10748426144270DRAPE ARMOUR™Microtek Medical LLCKPY2025-09-23
00748426143443DRAPE ARMOUR™Microtek Medical LLCKPY2025-09-23
00816611026052Halyard Scatter Radiation ShieldsANGIOSYSTEMS, INCORPORATEDKPY2025-01-30
00816611026069Halyard Scatter Radiation ShieldsANGIOSYSTEMS, INCORPORATEDKPY2025-01-30