AccessGUDID - DEVICE: KENEX (05055449410397)

GUDID

Device Identifier (DI) Information

Brand Name: KENEX
Version or Model: 300/L-LED150FP
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 300/L-LED150FP
Company Name: KENEX (ELECTRO-MEDICAL) LIMITED

Primary DI Number: 05055449410397
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 217421064 *Terms of Use

Device Description: LED 150FP Lamp and suspension arm only (for use with a Kenex celling radiation shield) inclu PSU

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
12276	Fixed examination/treatment room light	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KZF	Device, Medical Examination, Ac Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d898c9f4-6611-4fa7-9016-e285dbe81307
Public Version Date: July 11, 2023
Public Version Number: 2
DI Record Publish Date: January 16, 2023