Solarc/SolRx 100-Series

GUDID B219ARM1000

Positioning Arm Accessory for Solarc/SolRx 100-Series Ultraviolet Phototherapy Lamp Unit.

Solarc Systems Inc

Ultraviolet phototherapy unit, home-use
Primary Device IDB219ARM1000
NIH Device Record Key8330171e-0d8b-4050-93ce-8c7cf8be3833
Commercial Distribution StatusIn Commercial Distribution
Brand NameSolarc/SolRx 100-Series
Version Model NumberARM-100
Company DUNS256728031
Company NameSolarc Systems Inc
Device Count1
DM Exempttrue
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB219ARM1000 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-12-21
Device Publish Date2016-09-17

On-Brand Devices [Solarc/SolRx 100-Series]

B219ARM1000Positioning Arm Accessory for Solarc/SolRx 100-Series Ultraviolet Phototherapy Lamp Unit.
B219120UVBNB230V0Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 100-Series 2-BULB UVB-Narrowband Handheld Devic
B219120UVBNB0Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 100-Series 2-BULB UVB-Narrowband Handheld Devic
B219120UVB0Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 100-Series 2-BULB UVB-BROADBAND Handheld Device
B219110UVBNB230V0Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 100-Series 1-BULB UVB-Narrowband Handheld Devic
B219110UVBNB0Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 100-Series 1-BULB UVB-Narrowband Handheld Devic
B219110UVB0Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 100-Series 1-BULB UVB-BROADBAND Handheld Device

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