FDA.reportPublic FDA data

MasterPeace

Primary DI
07350121950924
Brand
MasterPeace
Company
Texray AB
Model
PS3450
Catalog number
PS3450
Device description
Patch for Patient to reduce scatter radiation, L-shape, Versatile Position.
Published
2025-05-21
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
07350121950528PreviousGS10
07350121950924PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350121950528073501219505287350121950528
07350121950924073501219509247350121950924

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’s body during a diagnostic or therapeutic radiological procedure to shield specific patient anatomies from unnecessary exposure to radiation and/or help block scatter radiation from the patient to protect healthcare workers.. 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length60Centimeter
Width60Centimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
350597560
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350121951037MasterPeaceTS1550TS15502026-04-06
07350121951044MasterPeaceTS4550TS45502026-04-06
07350121951068MasterPeaceTS6550TS65502026-04-06
07350121950887MasterPeacePS2250PS22502025-05-21
07350121950894MasterPeacePS3150PS31502025-05-21
07350121950900MasterPeacePS3250PS32502025-05-21
07350121950917MasterPeacePS3350PS33502025-05-21
07350121950931MasterPeacePS4050PS40502025-05-21
07350121950948MasterPeaceTS1050TS10502025-05-21
07350121950955MasterPeaceTS2050TS20502025-05-21
07350121950962MasterPeaceTS3050TS30502025-05-21
07350121950979MasterPeaceTS4050TS40502025-05-21
07350121950986MasterPeaceTS5050TS50502025-05-21
07350121950993MasterPeaceTS6050TS60502025-05-21
07350121951006MasterPeaceTS7050TS70502025-05-21
07350121951013MasterPeacePS4025PS40252025-05-21
07350121950818MasterPeacePS1150PS11502025-05-16
07350121950825MasterPeacePS1250PS12502025-05-16
07350121950832MasterPeacePS1350PS13502025-05-16
07350121950849MasterPeacePS1450PS14502025-05-16

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