AccessGUDID - DEVICE: RADIANCE 71i / 100W (04014501001035)

GUDID

Device Identifier (DI) Information

Brand Name: RADIANCE 71i / 100W
Version or Model: FR71 T12 100W PH / BiPin
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 26113
Company Name: NARVA Lichtquellen GmbH + Co KG.

Primary DI Number: 04014501001035
Issuing Agency: GS1
Commercial Distribution End Date: May 15, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 330119702 *Terms of Use

Device Description: No description.

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: 16fe8251-8d60-49d3-a589-286e6e168831
Public Version Date: May 17, 2022
Public Version Number: 3
DI Record Publish Date: June 09, 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
84014501001031	24	54014501401038	2022-05-15	Not in Commercial Distribution	Pallet
54014501401038	24	04014501001035	2022-05-15	Not in Commercial Distribution	Tertiary Packaging