AccessGUDID - DEVICE: S200 Series (Mobile, Ceiling, Dual Ceiling, Wall) (08800053081078)

GUDID

Device Identifier (DI) Information

Brand Name: S200 Series (Mobile, Ceiling, Dual Ceiling, Wall)
Version or Model: S200 MOBILE
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DENTIS CO. ,LTD

Primary DI Number: 08800053081078
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 694721181 *Terms of Use

Device Description: AC 100-240 V, 50/60 Hz, 58-74 VA

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":	No
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: 06f20824-a136-40f6-b140-c07056a2c10c
Public Version Date: January 31, 2024
Public Version Number: 1
DI Record Publish Date: January 23, 2024