FDA.report

KENEX

Primary DI
05055449403092
Brand
KENEX
Company
KENEX (ELECTRO-MEDICAL) LIMITED
Model
300/WL-LED130F
Catalog number
300/WL-LED130F
Device description
300/WL-LED130F LED 130F lamp with 2-part arm & wall bracket
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
KZFDevice, Medical Examination, Ac Powered

Product Code Classifications

CodeDeviceSpecialtyClass
KZFDevice, Medical Examination, Ac PoweredGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05055449403092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05055449403092050554494030925055449403092

GMDN Terms

TermDefinition
Fixed examination/treatment room lightA fixed device intended to provide light to illuminate a site of patient examination and/or treatment. It typically consists of one or more light bulb(s) and, depending upon the design, reflectors or mirrors which focus and reflect the light. The device can be fixed to a ceiling, wall, or supported on a mobile mount. It can also be part of an operating light system consisting of more than one light head.

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

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