FDA.reportPublic FDA data

Pediatric Half Apron

Primary DI
G031PHASRL0
Brand
Pediatric Half Apron
Company
Shielding International Inc.
Model
PHASRL
Device description
"Pediatric Half ApronPHAS-10"" x 10"" - 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
KPYShield, Protective, Personnel

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G031PHASRL0PrimaryHIBCC0

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
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