AccessGUDID - DEVICE: Premio 40 - Light (03760262493381)

GUDID

Device Identifier (DI) Information

Brand Name: Premio 40 - Light
Version or Model: PREMIO 40
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 112953
Company Name: SEDATELEC

Primary DI Number: 03760262493381
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 266031462 *Terms of Use

Device Description: The PREMIO 40 Light is an active device intended to illuminate an area or a point of the patient's body in the visible spectrum by a light emission which can be filtered and / or frequency.

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):	No
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
KYT	Light, Examination, Medical, Battery 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: 7ccd57e2-ef74-4bb7-8557-eda7b6c19d2e
Public Version Date: August 04, 2021
Public Version Number: 1
DI Record Publish Date: July 27, 2021