FDA.reportPublic FDA data

KENEX

Primary DI
05055449415675
Brand
KENEX
Company
KENEX (ELECTRO-MEDICAL) LIMITED
Model
1340/3/10/LR
Catalog number
1340/3/10/LR
Device description
1340/3/10/LR Mob Tableside Control Pedestal (10x25mmSect) & shield
Published
2023-07-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
05055449415675PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055449415675050554494156755055449415675

GMDN Terms#

Term, Definition table
TermDefinition
Radiation shielding panel, portable/mobileA portable or mobile rigid barrier designed to shield patients and healthcare professionals from unnecessary exposure to radiation used in diagnostic or therapeutic medical procedures. It provides a physical radiation-attenuating barrier between an individual and a source of primary or scattered radiation. It may be a stand-alone device or intended to be integrated within an electronic system; the panel itself is not electronic. The types of materials used depend on the type of radiation to be attenuated [e.g., those used in diagnostic x-ray and nuclear medicine consist of lead (Pb) or lead-equivalent materials, and those used to attenuate neutrons are composed of hydrogenous materials].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
217421064
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055449412490Kenex312/E-040/P312/E-040/P2026-04-27
05055449412445Kenex312/E-040312/E-0402026-04-24
05055449412438Kenex351/68/LED130F-0031351/68/LED130F-00312026-02-09
05055449412414Kenex312/E-020/3/P312/E-020/3/P2026-01-20
05055449412407Kenex313/A2-025313/A2-0252026-01-07
05055449412353Kenex312/DS-070312/DS-0702025-10-24
05055449412360Kenex312/DS-071312/DS-0712025-10-24
05055449412179Kenex313/A2-024313/A2-0242025-10-07
05055449412285Kenex354/P/88-207/LR354/P/88-207/LR2025-09-10
05055449409933Kenex354/P/76-107354/P/76-1072025-06-09
05055449412223Kenex354/P/76-207354/P/76-2072025-06-06
05055449405522KENEX312/E-023/P312/E-023/P2025-02-24
05055449412087KENEX313/A2-023313/A2-0232025-02-24
05055449412056KENEX313/A2/3.34313/A2/3.342025-01-16
05055449412070KENEX312/DS-0412/4312/DS-0412/42025-01-13
05055449412063KENEX313/A2-022313/A2-0222025-01-06
05055449411950KENEX312/E-017312/E-0172024-12-09
05055449411967KENEX312/E-017/8312/E-017/82024-12-09
05055449411974KENEX312/E-017/P312/E-017/P2024-12-09
05055449411981KENEX312/E-017/8P312/E-017/8P2024-12-09

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00814907020579ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-12
00814907020593ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-12
00814907020609ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-12
00814907020623ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-12
00814907020647ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-12
00814907020654ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-12
00814907020661ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-12
00814907020425ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-11
00814907020432ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-11
00814907020463ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-11
00814907020500ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-11
00814907020555ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-11
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