FDA.reportPublic FDA data

Kenex

Primary DI
05055449412438
Brand
Kenex
Company
KENEX (ELECTRO-MEDICAL) LIMITED
Model
351/68/LED130F-0031
Catalog number
351/68/LED130F-0031
Device description
351/68/LED130F-0031 60x80cm shield & arm,col,LED130F Lamp & AluTrack
Published
2026-02-09
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
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
05055449412438PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055449412438050554494124385055449412438

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
05055449412650Kenex303/B2/90-001303/B2/90-0012026-10-22
05055449412483Kenex354/P76/LED3DF-001354/P76/LED3DF-0012026-06-04
05055449412490Kenex312/E-040/P312/E-040/P2026-04-27
05055449412445Kenex312/E-040312/E-0402026-04-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00858340006578Del Medical, Inc.Del Medical, Inc.EAK2026-09-28
00860015605603Rampart Defender Radiation ShieldRampart Ic, LLCEAK2026-07-17
00860015605610Rampart VanguardRampart Ic, LLCEAK2026-07-17
05055449412483KenexKENEX (ELECTRO-MEDICAL) LIMITEDEAK2026-06-04
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
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