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
G031VBO2XFNL0Vest Only w/ BeltVBO2XFNL2026-07-13
G031VBO2XFRL0Vest Only w/ BeltVBO2XFRL2026-07-13
G031VBO2XFRLL0Vest Only w/ BeltVBO2XFRLL2026-07-13
G031VBO2XFTL0Vest Only w/ BeltVBO2XFTL2026-07-13
G031VBO2XFTLL0Vest Only w/ BeltVBO2XFTLL2026-07-13
G031VBO2XMNL0Vest Only w/ BeltVBO2XMNL2026-07-13
G031VBO2XMNLL0Vest Only w/ BeltVBO2XMNLL2026-07-13
G031VBO2XMRL0Vest Only w/ BeltVBO2XMRL2026-07-13
G031VBO2XMRLL0Vest Only w/ BeltVBO2XMRLL2026-07-13
G031VBO2XMTL0Vest Only w/ BeltVBO2XMTL2026-07-13
G031VBO2XMTLL0Vest Only w/ BeltVBO2XMTLL2026-07-13
G031VBOLFNL0Vest Only w/ BeltVBOLFNL2026-07-13
G031VBOLFNLL0Vest Only w/ BeltVBOLFNLL2026-07-13
G031VBOLFRL0Vest Only w/ BeltVBOLFRL2026-07-13
G031VBOLFRLL0Vest Only w/ BeltVBOLFRLL2026-07-13
G031VBOLFTL0Vest Only w/ BeltVBOLFTL2026-07-13
G031VBOLFTLL0Vest Only w/ BeltVBOLFTLL2026-07-13
G031VBOLMNL0Vest Only w/ BeltVBOLMNL2026-07-13
G031VBOLMNLL0Vest Only w/ BeltVBOLMNLL2026-07-13
G031VBOLMRL0Vest Only w/ BeltVBOLMRL2026-07-13

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