FDA.reportPublic FDA data

BMT Breast Shield

Primary DI
00860003072776
Brand
BMT Breast Shield
Company
CONCURE ONCOLOGY, INC.
Model
AC-B3110
Published
2020-08-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00860003072776PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003072776008600030727768600030727760860003072776

GMDN Terms#

Term, Definition table
TermDefinition
Patient radiation shielding pad/drape, reusableA protective device intended to be placed on/draped over part of a patient body (typically torso or chest) during a diagnostic or therapeutic radiological procedure, to shield specific patient anatomies from unnecessary exposure to radiation. It commonly consists of a fluid-resistant outer covering that surrounds a thin sheet of lead (Pb) or lead-equivalent material; it is not a piece of clothing such as an apron. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
056124661
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860005821204Obturator and Caps5303122021-04-19
00860005821211BMT Localizer Needle KitAC-B50002021-04-19
00860003072714BMT Template Grid Armature & Table ClampAC-B30302020-08-05
00860003072721BMT Armrest Armature & Table ClampAC-B30402020-08-05
00860003072738BMT Template Grid, Vertical Lock, LargeAC-B302052020-08-05
00860003072745BMT Cleaning Brush Set, Vertical LockAC-B305052020-08-05
00860003072752BMT Fiducial Needle, Sharp97-FN17202020-08-05
00860003072769BMT Fiducial Needle, Round80-FN17202020-08-05

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