AccessGUDID - DEVICE: KBL 8000 alpha extraSun+ (04260489020173)

GUDID

Device Identifier (DI) Information

Brand Name: KBL 8000 alpha extraSun+
Version or Model: KBL 7908 - 50-6T12/4g 1616 int us (T)
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KBL GmbH

Primary DI Number: 04260489020173
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 341936227 *Terms of Use

Device Description: This device is an over-the-counter device emitting ultraviolet light in the UVB and UVA region of the spectrum intended for tanning of the human skin of an adult person.

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):	Yes
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?
46387	Ultraviolet tanning device	A mains electricity (AC-powered) lamp or bed/booth with lamps designed to provide radiation in the ultraviolet spectrum for tanning the skin. This device is used for cosmetic purposes.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LEJ	Booth, Sun Tan

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K151962	000

Device Exempt from Premarket Submission: No 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: 6fe475c3-938f-4fbe-a6d7-c33eab8ae2d5
Public Version Date: August 10, 2021
Public Version Number: 1
DI Record Publish Date: August 02, 2021