FDA.reportPublic FDA data

MasterPeace

Primary DI
07350121950719
Brand
MasterPeace
Company
Texray AB
Model
Patient upper right variants
Catalog number
PS1650
Device description
Patient shield to be attached to patient upper right variants. Hook and loop on the right side.
Published
2025-02-18
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
07350121950719PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350121950719073501219507197350121950719

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
Length40Centimeter
Width45Centimeter

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
07350121950924MasterPeacePS3450PS34502025-05-21
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

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