FDA.reportPublic FDA data

RADPAD

Primary DI
00852814003582
Brand
RADPAD
Company
WORLDWIDE INNOVATIONS & TECHNOLOGIES, INC.
Model
9912-O
Device description
Fig Leaf Preemie Gonadal Shield - Orange
Published
2020-07-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Single use
true

Product Codes#

Code, Name table
CodeName
IWTShield, gonadal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWTShield, GonadalRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10852814003589PackageGS115In Commercial Distribution
00852814003582PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085281400358910852814003589
00852814003582008528140035828528140035820852814003582

GMDN Terms#

Term, Definition table
TermDefinition
Patient radiation shielding pad/drape, reusableA 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 reusable 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
00850013127108RADPAD5110A-B2020-07-17
00852814003339RADPAD5700-O-NS2017-01-19
00852814003568RADPAD9911-Y2020-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G031806ARL0Gonad Shield - set of 3 - no closureShielding International Inc.IWT2023-10-12
G031806SQRRL0Gonad Shield w/ QR BuckleShielding International Inc.IWT2023-10-12
G031806SRL0Gonad ShieldShielding International Inc.IWT2023-10-12
G031806STRL0Gonad Shield w/ TiesShielding International Inc.IWT2023-10-12
G031806SVRL0Gonad Shield w/ Hook & LoopShielding International Inc.IWT2023-10-12
G031807SQRRL0Ova Shield w/ hook & loopShielding International Inc.IWT2023-10-12
G031807SRL0Ova Shield - no closureShielding International Inc.IWT2023-10-12
G031807STRL0Ova Shield - w/ TiesShielding International Inc.IWT2023-10-12
G031807SVRL0Ova Shield w/ hook & loopShielding International Inc.IWT2023-10-12
G031822BBVRL0Gonadal & Ovarian Belt SystemShielding International Inc.IWT2023-10-12
00840348529227RayshieldAADCO MEDICAL, INC.IWT2023-06-23
00840348529234RayshieldAADCO MEDICAL, INC.IWT2023-06-23
00840348529241RayshieldAADCO MEDICAL, INC.IWT2023-06-23
00840348529258RayshieldAADCO MEDICAL, INC.IWT2023-06-23
00840348529265RayshieldAADCO MEDICAL, INC.IWT2023-06-23
G242GL5L9Techno-AideTechno-Aide, Inc.IWT2023-02-10
G242GL5N9Techno-AideTechno-Aide, Inc.IWT2023-02-10
G242GL5R9Techno-AideTechno-Aide, Inc.IWT2023-02-10
G242GM5L9Techno-AideTechno-Aide, Inc.IWT2023-02-10
G242GM5N9Techno-AideTechno-Aide, Inc.IWT2023-02-10
G242GM5R9Techno-AideTechno-Aide, Inc.IWT2023-02-10
G242GS5L9Techno-AideTechno-Aide, Inc.IWT2023-02-10
G242GS5N9Techno-AideTechno-Aide, Inc.IWT2023-02-10
G242GS5R9Techno-AideTechno-Aide, Inc.IWT2023-02-10
G242GL5L90Techno-AideTechno-Aide, Inc.IWT2023-02-10
G242GL5N90Techno-AideTechno-Aide, Inc.IWT2023-02-10
G242GL5R90Techno-AideTechno-Aide, Inc.IWT2023-02-10
G242GM5L90Techno-AideTechno-Aide, Inc.IWT2023-02-10
G242GM5N90Techno-AideTechno-Aide, Inc.IWT2023-02-10
G242GM5R90Techno-AideTechno-Aide, Inc.IWT2023-02-10