FDA.reportPublic FDA data

Panelite Unit, 12 Visible Lamp Unit

Primary DI
B27672P12VB0
Brand
Panelite Unit, 12 Visible Lamp Unit
Company
ULTRALITE ENTERPRISES INC
Model
72P12VB
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IOBLamp, Infrared, Non Heating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IOBLamp, Infrared, Non HeatingPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B27672P12VB0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ultraviolet phototherapy unit, home-useA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7709630594support@ultraliteuv.com

Regulatory Flags#

DUNS number
070327895
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B27672P08NB0Panelite Home Unit, 8 UVB Lamps72P08NB2016-09-23
B276HFDL28A0Hand and Foot Unit, 28 UVA Lamp UnitHFDL28A2016-09-23
B276HFDL28NB0Hand and Foot Unit, 28 UVB Lamp UnitHFDL28NB2016-09-23
B276V44000Full Body Unit, 44 UVA Lamp UnitV44002016-09-23
B276V4422ANB0Full Body Unit, 44 Lamp UVA/UVB Combination UnitV4422ANB2016-09-23
B276V4444NB0Full Body Unit, 44 UVB lampsV4444NB2016-09-23
B276V48000Full Body Unit, 48 Lamp UVA UnitV48002016-09-23
B276V4824ANB0Full Body Unit, 48 UVA/UVB Combination UnitV4824ANB2016-09-23
B276V4848NB0Full Body Unit, 48 UVB LampsV4848NB2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816878020817National Biological CorporationNATIONAL BIOLOGICAL CORPORATIONIOB2018-01-25
00816878020138National Biological CorporationNATIONAL BIOLOGICAL CORPORATIONIOB2017-03-10
00816878020145National Biological CorporationNATIONAL BIOLOGICAL CORPORATIONIOB2017-03-10
00816878020152National Biological CorporationNATIONAL BIOLOGICAL CORPORATIONIOB2017-03-10
00816878020169National Biological CorporationNATIONAL BIOLOGICAL CORPORATIONIOB2017-03-10
00816878020176National Biological CorporationNATIONAL BIOLOGICAL CORPORATIONIOB2017-03-10
00816878020183National Biological CorporationNATIONAL BIOLOGICAL CORPORATIONIOB2017-03-10
00816878020794National Biological CorporationNATIONAL BIOLOGICAL CORPORATIONIOB2017-03-10
B27672P08NB0Panelite Home Unit, 8 UVB LampsULTRALITE ENTERPRISES INCIOB2016-09-23