FDA.reportPublic FDA data

MasterPeace

Primary DI
07350121950979
Brand
MasterPeace
Company
Texray AB
Model
TS4050
Catalog number
TS4050
Device description
Table-Mounted Radiation Source Leakage shield, Verticle, Position Right.
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
IWXBarrier, Control Panel, X-Ray, Movable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWXBarrier, Control Panel, X-Ray, MovableRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350121950573PreviousGS10
07350121950979PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350121950573073501219505737350121950573
07350121950979073501219509797350121950979

GMDN Terms#

Term, Definition table
TermDefinition
Radiation shielding table drapeA protective device intended to be placed on/draped over part of an operating table for a radiological examination during a surgical procedure (e.g. fluoroscopy using a C-arm) to shield attending healthcare personnel 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 which may in part be segmented into strips to allow passage of equipment under the table. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length60Centimeter
Width90Centimeter

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
07350121950986MasterPeaceTS5050TS50502025-05-21
07350121950993MasterPeaceTS6050TS60502025-05-21
07350121951006MasterPeaceTS7050TS70502025-05-21
07350121951013MasterPeacePS4025PS40252025-05-21
07350121950818MasterPeacePS1150PS11502025-05-16
07350121950825MasterPeacePS1250PS12502025-05-16
07350121950832MasterPeacePS1350PS13502025-05-16
07350121950849MasterPeacePS1450PS14502025-05-16

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Primary DI, Brand, Company table
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