FDA.reportPublic FDA data

RADPAD

Primary DI
00852814003186
Brand
RADPAD
Company
WORLDWIDE INNOVATIONS & TECHNOLOGIES, INC.
Model
7100A-Y
Device description
Femoral Angiography Drape Right Side-Yellow
Published
2016-10-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PUIDrape, surgical, exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUIDrape, Surgical, ExemptGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10852814003183PackageGS112In Commercial Distribution
00852814003186PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085281400318310852814003183
00852814003186008528140031868528140031860852814003186

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
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
00850013127108RADPAD5110A-B2020-07-17
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
08684382977444SUBMEDSU BIYOMEDIKAL SISTEMLER VE SAGLIK HIZMETLERI SANAYI VE TICARET ANONIM SIRKETIPUI2026-10-20
08684382977451SUBMEDSU BIYOMEDIKAL SISTEMLER VE SAGLIK HIZMETLERI SANAYI VE TICARET ANONIM SIRKETIPUI2026-10-20
08684382999712SUBMEDSU BIYOMEDIKAL SISTEMLER VE SAGLIK HIZMETLERI SANAYI VE TICARET ANONIM SIRKETIPUI2026-10-20
00850067913238SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-16
00850067913245SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-16
00850067913252SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-16
00850067913269SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-16
00850067913276SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-16
00850067913283SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-16
00850067913085SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913092SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913108SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913115SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913122SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913139SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913146SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913153SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913160SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913191SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913214SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913221SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00748426264575Medline-MicrotekMicrotek Medical LLCPUI2026-10-14
10192253072211CONVERTORSCardinal Health 200, LLCPUI2026-10-14
10192253072228CONVERTORSCardinal Health 200, LLCPUI2026-10-14
10192253072235CONVERTORSCardinal Health 200, LLCPUI2026-10-14
10192253072242CONVERTORSCardinal Health 200, LLCPUI2026-10-14
10192253072259CONVERTORSCardinal Health 200, LLCPUI2026-10-14
20193489029946MedlineMEDLINE INDUSTRIES, INC.PUI2026-10-14
20748426264531Medline-MicrotekMicrotek Medical LLCPUI2026-10-14
20748426264593Medline-MicrotekMicrotek Medical LLCPUI2026-10-14