Primary Device ID | B219ARM1000 |
NIH Device Record Key | 8330171e-0d8b-4050-93ce-8c7cf8be3833 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Solarc/SolRx 100-Series |
Version Model Number | ARM-100 |
Company DUNS | 256728031 |
Company Name | Solarc Systems Inc |
Device Count | 1 |
DM Exempt | true |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B219ARM1000 [Primary] |
FTC | Light, Ultraviolet, Dermatological |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2018-12-21 |
Device Publish Date | 2016-09-17 |
B219ARM1000 | Positioning Arm Accessory for Solarc/SolRx 100-Series Ultraviolet Phototherapy Lamp Unit. |
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