FDA.report

KENEX

Primary DI
05055449401500
Brand
KENEX
Company
KENEX (ELECTRO-MEDICAL) LIMITED
Model
300/P/014
Catalog number
300/P/014
Device description
300/P/014 Ceiling anchorage ring & plate
Published
2023-07-12
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

Related Records

Product Codes

CodeName
EAKScreen, Leaded, Operator Radiation Protector

Product Code Classifications

CodeDeviceSpecialtyClass
EAKScreen, Leaded, Operator Radiation ProtectorRadiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05055449401500PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05055449401500050554494015005055449401500

GMDN Terms

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.

Sterilization Methods

Method

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 DIBrandModelCatalogPublished
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
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
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
05055449411998KENEX312/DS-039/4/3312/DS-039/4/32024-12-09
05055449412001KENEX312/DS-039/4312/DS-039/42024-12-09
05055449412018KENEX351/LR/80/SP/30351/LR/80/SP/302024-12-09
05055449412025KENEX333/OPT-006333/OPT-0062024-12-09
05055449415705KENEX1330/51330/52022-12-08
05055449415910KENEX1330/31330/32022-12-08
05055449415934KENEX1330/41330/42022-12-08

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
05055449412438KenexKENEX (ELECTRO-MEDICAL) LIMITEDEAK2026-02-09
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
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
05055449400022KENEXKENEX (ELECTRO-MEDICAL) LIMITEDEAK2023-07-21
05055449400046KENEXKENEX (ELECTRO-MEDICAL) LIMITEDEAK2023-07-21
05055449400077KENEXKENEX (ELECTRO-MEDICAL) LIMITEDEAK2023-07-21
05055449400084KENEXKENEX (ELECTRO-MEDICAL) LIMITEDEAK2023-07-21
05055449400138KENEXKENEX (ELECTRO-MEDICAL) LIMITEDEAK2023-07-21
05055449400190KENEXKENEX (ELECTRO-MEDICAL) LIMITEDEAK2023-07-21
05055449400237KENEXKENEX (ELECTRO-MEDICAL) LIMITEDEAK2023-07-21
05055449400251KENEXKENEX (ELECTRO-MEDICAL) LIMITEDEAK2023-07-21
05055449400268KENEXKENEX (ELECTRO-MEDICAL) LIMITEDEAK2023-07-21
05055449400275KENEXKENEX (ELECTRO-MEDICAL) LIMITEDEAK2023-07-21
05055449401159KENEXKENEX (ELECTRO-MEDICAL) LIMITEDEAK2023-07-21