FDA.reportPublic FDA data

National Biological Corporation

Primary DI
00816878020060
Brand
National Biological Corporation
Company
NATIONAL BIOLOGICAL CORPORATION
Model
UVA-806
Published
2017-03-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FTCLight, Ultraviolet, Dermatological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTCLight, Ultraviolet, DermatologicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K827890000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K827890000FOLDALITE UNITNational Biological Corp.1982-08-23FTC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816878020060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816878020060008168780200608168780200600816878020060

GMDN Terms#

Term, Definition table
TermDefinition
Ultraviolet phototherapy unit, professionalA mains electricity (AC-powered) device with special lamps that emit ultraviolet B (UVB), or UVB and ultraviolet A (UVA) radiation intended to be used by a healthcare professional to treat a variety of dermatological disorders (e.g., psoriasis). The device is typically designed as a flat surface for lying with an overhead lamp(s), or as a chamber/cabinet, in which the patient stands, with interior walls lined with ultraviolet (UV) light tubes to allow full-body exposure and an even distribution of UV radiation. The device intended use may include psoralen + UVA therapy (oral administration of psoralen and subsequent exposure to UVA) (PUVA).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
046198420
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816878020671HandisolUVB-150-22024-04-03
00816878020800HandisolUVB-150-12024-04-03
00816878020893Panosol 6UVB-6402024-03-13
00816878020909Panosol 6UVB-6602024-03-13
00816878020916Panosol 6UVA-6402024-03-13
00816878020923Panosol 6UVA-6602024-03-13
00816878020930Panosol 6-3DUVB-6802024-03-13
00816878020947Panosol 6-3DUVB-6122024-03-13
00816878020954Panosol 6-3DUVA-6802024-03-13
00816878020961Panosol 6-3DUVA-6122024-03-13
00816878020008National Biological CorporationUVA-1182017-03-10
00816878020015National Biological CorporationUVA-2182017-03-10
00816878020022National Biological CorporationUVA-6162017-03-10
00816878020039National Biological CorporationUVA-6262017-03-10
00816878020046National Biological CorporationUVA-8022017-03-10
00816878020077National Biological CorporationUVA-806A2017-03-10
00816878020084National Biological CorporationUVA-8072017-03-10
00816878020091National Biological CorporationUVA-807A2017-03-10
00816878020107National Biological CorporationUVA-8122017-03-10
00816878020138National Biological CorporationUVB-0802017-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06946725599990APKAPK Technology Co.,Ltd.FTC2025-09-22
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B219E790MUVBNB0Solarc/SolRx E-SeriesSolarc Systems IncFTC2025-04-01
06928798600377KernelXuzhou Kernel Medical Equipment Co., Ltd.FTC2025-03-11
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06928798600421KernelXuzhou Kernel Medical Equipment Co., Ltd.FTC2025-03-11
06928798600438KernelXuzhou Kernel Medical Equipment Co., Ltd.FTC2025-03-11
06928798600445KernelXuzhou Kernel Medical Equipment Co., Ltd.FTC2025-03-11
06928798600452KernelXuzhou Kernel Medical Equipment Co., Ltd.FTC2025-03-11
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