FDA.reportPublic FDA data

Comfort Fit w/ Breast Cancer logo

Primary DI
G031641BCSRL0
Brand
Comfort Fit w/ Breast Cancer logo
Company
Shielding International Inc.
Model
641BCSRL
Device description
"Comfort Fit w/ Breast Cancer logo641BC Small - 24"" L - 0.5mm Reg 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
G031641BCSRL0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiation shielding collarA personal protective device intended to shield the neck area including the nape, the throat, and the thyroid of an individual (i.e., a device operator or other attending person) from unnecessary exposure to radiation during diagnostic or therapeutic medical and dental procedures. Collars used in x-ray and nuclear medicine typically consist of a fluid resistant outer covering surrounding a thin sheet of lead (Pb) or lead-equivalent material. Collars used for neutron attenuation are composed of hydrogenous materials instead of lead; 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
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10748426143433Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
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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