FDA.reportPublic FDA data

Smock Top Half Back Apron

Primary DI
G031SMHBSLFL0
Brand
Smock Top Half Back Apron
Company
Shielding International Inc.
Model
SMHBSLFL
Device description
Smock Top Half Back ApronSmall - Lead Free: 0.35mm Front / 0.25mm Back (LFL)
Published
2023-10-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
G031SMHBSLFL0PrimaryHIBCC0

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
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
G242TC3N90Techno-AideTechno-Aide, Inc.IWO2025-12-22
00817169029380Visionary By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCIWO2025-12-16
G309SG20Stevens-MoonStevens-Moon Sales Professionals LLCIWO2025-05-21
G242J23N90Techno-AideTechno-Aide, Inc.IWO2024-11-14
G242J25N90Techno-AideTechno-Aide, Inc.IWO2024-11-14
G242JL3N90Techno-AideTechno-Aide, Inc.IWO2024-11-14
G242JL5N90Techno-AideTechno-Aide, Inc.IWO2024-11-14
G242JM3N90Techno-AideTechno-Aide, Inc.IWO2024-11-14
G242JX3N90Techno-AideTechno-Aide, Inc.IWO2024-11-14
G242JX5N90Techno-AideTechno-Aide, Inc.IWO2024-11-14
G242JM5N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
G242JP3N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
G242JP5N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
G242JS3N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
G242JS5N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
G242K23N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
G242K25N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
G242KL3N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
G242KL5N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
G242KM3N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
G242KM5N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
G242KP3N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
G242KP5N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
G242KS3N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
G242KS5N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
G242KX3N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
G242KX5N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
00197513011897Thyroid Shield BATBURLINGTON MEDICAL, LLCIWO2024-08-26
00197513011903Thyroid Shield BATBURLINGTON MEDICAL, LLCIWO2024-08-26
00197513011910Thyroid Shield BATBURLINGTON MEDICAL, LLCIWO2024-08-26