AccessGUDID - DEVICE: Peacock Tanning (B343HT1000)

GUDID

Device Identifier (DI) Information

Brand Name: Peacock Tanning
Version or Model: 1000HT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1000HT
Company Name: Medtek Lighting Corporation

Primary DI Number: B343HT1000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002692106 *Terms of Use

Device Description: Suntan Unit. One Panel with ten 72" suntan lamps. Panel is wall mounted.

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 [?]
Premarket Submission Number Not Available/Not Released

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
Area/Surface Area: 1311 Square inch
Weight: 180 Pound

Device Record Status

Public Device Record Key: ef6a3879-394f-4fc4-b796-76b0c461734c
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: February 09, 2017