AccessGUDID - DEVICE: MILLENNIUM M2 3.15 / 160W-180W / SM (04014501003398)

GUDID

Device Identifier (DI) Information

Brand Name: MILLENNIUM M2 3.15 / 160W-180W / SM
Version or Model: FR71 T12 160W HO PH / BiPin
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2899 6
Company Name: NARVA Lichtquellen GmbH + Co KG.

Primary DI Number: 04014501003398
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 330119702 *Terms of Use
Previous DI: 04014501001592

Device Description: UV - Tanning lamp, Accession # 102 0626-001 <CR> Exclusive distributor for USA: JW North America, Inc., 233 Libbey Industrial Pkwy, Unit 2, Weymouth, MA 02189, Phone: +1 781 331 0949, Email: kapgar@jwnorthamerica.com <CR> Manufacturer: NARVA Lichtquellen GmbH + Co. KG, Industriegebiet Nord, Erzstrasse 22, 09618 Brand-Erbisdorf, Germany, Phone: +49 37322 17 200, Email: office@narva-bel.de, http://www.narva-bel.de

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
Special Storage Condition, Specify: Keep dry. Attention: Fragile.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 01baca65-abd0-444d-8ae0-f518857d4f39
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: November 09, 2017