AccessGUDID - DEVICE: Panelite Unit, 12 Visible Lamp Unit (B27672P12VB0)

GUDID

Device Identifier (DI) Information

Brand Name: Panelite Unit, 12 Visible Lamp Unit
Version or Model: 72P12VB
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ULTRALITE ENTERPRISES INC

Primary DI Number: B27672P12VB0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 070327895 *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):	Yes
Over the Counter (OTC):	No
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?
34669	Ultraviolet phototherapy unit, home-use	A mains electricity (AC-powered), portable, device that includes a lamp which emits light in the ultraviolet (UV) band intended to treat dermatological disorders (e.g., psoriasis, dermatitis) in the home.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IOB	Lamp, Infrared, Non Heating

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
No Device Sizes

Device Record Status

Public Device Record Key: 91aa9ee2-5a2f-48c7-94b1-0e882941f45b
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016