FDA.reportPublic FDA data

Gonad Shield - set of 3 - no closure

Primary DI
G031806ARL0
Brand
Gonad Shield - set of 3 - no closure
Company
Shielding International Inc.
Model
806ARL
Device description
Gonad Shield - Plain - Set of 3 (S,M, L) - 0.5mm Regular Lead (RL)
Published
2023-10-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
G031806ARL0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Gonad radiation shieldA personal protective device intended to shield the gonads of an individual (i.e., a device operator, patient, or other attending person) from unnecessary exposure to radiation from diagnostic medical and dental procedures by providing an attenuating barrier to the radiation. It comes in various configurations: 1) anatomically designed to fit over the gonads; 2) placed directly on the body; or 3) attached to the wall or radiation delivery device on an articulating arm. Radiation protection male and female gonadal shields are typically made of lead (Pb) or lead-equivalent material.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
009647322
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G031QRSOMFRL0Quick Release Skirt OnlyQRSOMFRL2026-04-28
G031QRSOMMNL0Quick Release Skirt OnlyQRSOMMNL2026-04-28
G031QRSOMMRL0Quick Release Skirt OnlyQRSOMMRL2026-04-28
G031QRSOMMRLL0Quick Release Skirt OnlyQRSOMMRLL2026-04-28
G031QRSOMMTL0Quick Release Skirt OnlyQRSOMMTL2026-04-28
G031QRSOSFNL0Quick Release Skirt OnlyQRSOSFNL2026-04-28
G031QRSOSFRL0Quick Release Skirt OnlyQRSOSFRL2026-04-28
G031QRSOSFRLL0Quick Release Skirt OnlyQRSOSFRLL2026-04-28
G031QRSOSFTL0Quick Release Skirt OnlyQRSOSFTL2026-04-28
G031QRSOSMNL0Quick Release Skirt OnlyQRSOSMNL2026-04-28
G031QRSOSMTL0Quick Release Skirt OnlyQRSOSMTL2026-04-28
G031QRSOSMRLL0Quick Release Skirt OnlyQRSOSMRLL2026-04-22
G031SO2XFRL0SkirtSO2XFRL2026-04-22
G031SO2XFRLL0SkirtSO2XFRLL2026-04-22
G031SO2XFTL0SkirtSO2XFTL2026-04-22
G031SO2XMNL0SkirtSO2XMNL2026-04-22
G031SO2XMRL0SkirtSO2XMRL2026-04-22
G031SO2XMRLL0SkirtSO2XMRLL2026-04-22
G031SO2XMTL0SkirtSO2XMTL2026-04-22
G031SOLFNL0SkirtSOLFNL2026-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
G242GS5L90Techno-AideTechno-Aide, Inc.IWT2023-02-10