FDA.reportPublic FDA data

Kenex

Primary DI
05055449412483
Brand
Kenex
Company
KENEX (ELECTRO-MEDICAL) LIMITED
Model
354/P76/LED3DF-001
Catalog number
354/P76/LED3DF-001
Device description
354/P76/LED3DF-001 76x61cm shield with arm, column& LED 300DF SC lamp
Published
2026-06-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
EAKScreen, Leaded, Operator Radiation Protector

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EAKScreen, Leaded, Operator Radiation ProtectorRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055449412483PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055449412483050554494124835055449412483

GMDN Terms#

Term, Definition table
TermDefinition
Radiation shielding panel, fixedA permanently installed device forming a structural barrier designed to block or attenuate radiation emissions from a primary or scattered radiation source. It includes various solid or transparent barriers typically used to shield patients from unnecessary exposure to radiation emitted from, e.g., diagnostic/therapeutic radiation emitting devices. It may also be used to shield a patient undergoing a diagnostic or therapeutic procedure requiring the administration of a radioactive material or placement of a radioactive source. The barrier can be permanently attached to the floor, wall or ceiling or to a medical device, or mounted on articulating structures giving a limited range of motion.

Regulatory Flags#

DUNS number
217421064
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860010101285Rampart Head ShieldRampart Ic, LLCEAK2026-04-27
04251339907669OTMAVIG GmbHEAK2026-04-14
04251339906822OTMAVIG GmbHEAK2026-02-12
04251339907263OTMAVIG GmbHEAK2026-02-12
04251339907270OTMAVIG GmbHEAK2026-02-12
04251339907287OTMAVIG GmbHEAK2026-02-12
04251339907294OTMAVIG GmbHEAK2026-02-12
04251339907409OTMAVIG GmbHEAK2026-02-12
05055449412438KenexKENEX (ELECTRO-MEDICAL) LIMITEDEAK2026-02-09
05055449412285KenexKENEX (ELECTRO-MEDICAL) LIMITEDEAK2025-09-10
00860010101230Sentry Radiation ShieldRampart Ic, LLCEAK2025-08-29
00860010101254Liberty Floor StandRampart Ic, LLCEAK2025-08-08
05055449409933KenexKENEX (ELECTRO-MEDICAL) LIMITEDEAK2025-06-09
05055449412223KenexKENEX (ELECTRO-MEDICAL) LIMITEDEAK2025-06-06
G242MB2430G209Techno-AideTechno-Aide, Inc.EAK2025-05-05
G242MB3060G209Techno-AideTechno-Aide, Inc.EAK2025-05-05
G242MB2430G2090Techno-AideTechno-Aide, Inc.EAK2025-05-05
G242MB3060G2090Techno-AideTechno-Aide, Inc.EAK2025-05-05
00860010101209Defender Radiation ShieldRampart Ic, LLCEAK2025-04-07
00860010101247Guardian Radiation ShieldRampart Ic, LLCEAK2025-04-07
00850067930020EggNestEGG Medical, Inc.EAK2025-03-16
05055449412018KENEXKENEX (ELECTRO-MEDICAL) LIMITEDEAK2024-12-09
04251339906280OTMAVIG GmbHEAK2024-06-03
04251339906297OTMAVIG GmbHEAK2024-06-03
04251339906006OTMAVIG GmbHEAK2024-04-19
04251339906013OTMAVIG GmbHEAK2024-04-19
00860002090108Rampart Rampart Ic, LLCEAK2023-08-25
00860002090177Rampart Rampart Ic, LLCEAK2023-08-25
00860002090184RampartRampart Ic, LLCEAK2023-08-25
00860002090191Rampart Rampart Ic, LLCEAK2023-08-25