4-Lamp 2' Panosol

GUDID 00816878020879

NATIONAL BIOLOGICAL CORPORATION

Ultraviolet phototherapy unit, home-use Ultraviolet phototherapy unit, home-use Ultraviolet phototherapy unit, home-use
Primary Device ID00816878020879
NIH Device Record Key4de7e4e1-f59c-4211-8505-19e99ec30750
Commercial Distribution StatusIn Commercial Distribution
Brand Name4-Lamp 2' Panosol
Version Model NumberUVB-241
Company DUNS046198420
Company NameNATIONAL BIOLOGICAL CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816878020879 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FTCLight, Ultraviolet, Dermatological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-11-16
Device Publish Date2018-10-16