AccessGUDID - DEVICE: Ergoline SR Super Power (04014501003480)

GUDID

Device Identifier (DI) Information

Brand Name: Ergoline SR Super Power
Version or Model: FR71T12 100W-R
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 901935140
Company Name: NARVA Lichtquellen GmbH + Co KG.

Primary DI Number: 04014501003480
Issuing Agency: GS1
Commercial Distribution End Date: February 14, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 330119702 *Terms of Use

Device Description: UV - Tanning lamp, Accession # 122 0531-000 <CR> Exclusive distributor for USA: JW North America, Inc., 233 Libbey Industrial Pkwy 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: 7b99514f-290a-4454-9378-af9e5d9e2321
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: December 21, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
84014501003486	24	54014501403483	2018-02-14	Not in Commercial Distribution	PAllet
54014501403483	24	04014501003480	2018-02-14	Not in Commercial Distribution	Tertiary Packaging