FDA.reportPublic FDA data

RP

Primary DI
04251339906259
Brand
RP
Company
MAVIG GmbH
Model
RP6435L22SB12-PH
Device description
RP - Radiation Protective Clothing PatientGonad Apron Model RP643-STD
Published
2024-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EAJApron, Leaded
IWOApron, Protective

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EAJApron, LeadedRadiology1
IWOApron, ProtectiveRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251339906259PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251339906259042513399062594251339906259

GMDN Terms#

Term, Definition table
TermDefinition
Gonad radiation shieldA personal protective device intended to shield the gonads of an individual (i.e., a device operator, patient, or other attending person) from unnecessary exposure to radiation from diagnostic medical and dental procedures by providing an attenuating barrier to the radiation. It comes in various configurations: 1) anatomically designed to fit over the gonads; 2) placed directly on the body; or 3) attached to the wall or radiation delivery device on an articulating arm. Radiation protection male and female gonadal shields are typically made of lead (Pb) or lead-equivalent material.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
317502326
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04251339907669OTOT0294-EMC2026-04-14
04251339901520WDWD260/100/120E2026-02-12
04251339906082WDWD204-05172026-02-12
04251339906815UTUT70-10WS-PH2026-02-12
04251339906822OTOT5500292026-02-12
04251339907263OTOT5100252026-02-12
04251339907270OTOT5000892026-02-12
04251339907287OTOT5400342026-02-12
04251339907294OTOT580012026-02-12
04251339907393UTE-UT60U0642026-02-12
04251339907409OTE-OT54B01V50S2026-02-12
04251339906242RPRP6435M22SB12-PH2024-06-03
04251339906266RPRP6435X22SB12-PH2024-06-03
04251339906273RPRP6435S22SB12-PH2024-06-03
04251339906280OTOT54001I-MQ2024-06-03
04251339906297OTOT50001I-MQ2024-06-03
04251339906006OTPTZTS2002OT812024-04-19
04251339906013OTPTZTS2005OT812024-04-19
04251339900370WDWD26105 2023-07-13
04251339900387WDWD26105-S 2023-07-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G031QRSO2XFNL0Quick Release Skirt OnlyShielding International Inc.EAJ2026-07-07
G031QRSO2XFNL0Quick Release Skirt OnlyShielding International Inc.IWO2026-07-07
G031QRSO2XFRL0Quick Release Skirt OnlyShielding International Inc.IWO2026-07-07
G031QRSO2XFRL0Quick Release Skirt OnlyShielding International Inc.EAJ2026-07-07
G031QRSO2XFRLL0Quick Release Skirt OnlyShielding International Inc.IWO2026-07-07
G031QRSO2XFRLL0Quick Release Skirt OnlyShielding International Inc.EAJ2026-07-07
G031QRSO2XFTL0Quick Release Skirt OnlyShielding International Inc.IWO2026-07-07
G031QRSO2XFTL0Quick Release Skirt OnlyShielding International Inc.EAJ2026-07-07
G031QRSO2XMNL0Quick Release Skirt OnlyShielding International Inc.IWO2026-07-07
G031QRSO2XMNL0Quick Release Skirt OnlyShielding International Inc.EAJ2026-07-07
G031QRSO2XMRL0Quick Release Skirt OnlyShielding International Inc.IWO2026-07-07
G031QRSO2XMRL0Quick Release Skirt OnlyShielding International Inc.EAJ2026-07-07
G031QRSO2XMRLL0Quick Release Skirt OnlyShielding International Inc.IWO2026-07-07
G031QRSO2XMRLL0Quick Release Skirt OnlyShielding International Inc.EAJ2026-07-07
G031QRSO2XMTL0Quick Release Skirt OnlyShielding International Inc.EAJ2026-07-07
G031QRSO2XMTL0Quick Release Skirt OnlyShielding International Inc.IWO2026-07-07
G031QRSOLFRL0Quick Release Skirt OnlyShielding International Inc.IWO2026-07-07
G031QRSOLFRL0Quick Release Skirt OnlyShielding International Inc.EAJ2026-07-07
G031QRSOLMNL0Quick Release Skirt OnlyShielding International Inc.IWO2026-07-07
G031QRSOLMNL0Quick Release Skirt OnlyShielding International Inc.EAJ2026-07-07
G031QRSOLMRL0Quick Release Skirt OnlyShielding International Inc.IWO2026-07-07
G031QRSOLMRL0Quick Release Skirt OnlyShielding International Inc.EAJ2026-07-07
G031QRSOLMRLL0Quick Release Skirt OnlyShielding International Inc.IWO2026-07-07
G031QRSOLMRLL0Quick Release Skirt OnlyShielding International Inc.EAJ2026-07-07
G031QRSOLMTL0Quick Release Skirt OnlyShielding International Inc.IWO2026-07-07
G031QRSOLMTL0Quick Release Skirt OnlyShielding International Inc.EAJ2026-07-07
G031QRSOMFNL0Quick Release Skirt OnlyShielding International Inc.IWO2026-07-07
G031QRSOMFTL0Quick Release Skirt OnlyShielding International Inc.IWO2026-07-07
G031QRSOXLFNL0Quick Release Skirt OnlyShielding International Inc.IWO2026-07-07
G031QRSOXLFNL0Quick Release Skirt OnlyShielding International Inc.EAJ2026-07-07