Panosol II Cabinet

GUDID 00816878020855

NATIONAL BIOLOGICAL CORPORATION

Ultraviolet phototherapy unit, professional
Primary Device ID00816878020855
NIH Device Record Key253189b9-eb63-4d47-b2ae-1d7ffc1508a9
Commercial Distribution StatusIn Commercial Distribution
Brand NamePanosol II Cabinet
Version Model NumberUVB-651
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 HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100816878020855 [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 Number2
Public Version Date2018-12-21
Device Publish Date2018-07-20

Devices Manufactured by NATIONAL BIOLOGICAL CORPORATION

00816878020671 - Handisol2024-04-11
00816878020800 - Handisol2024-04-11
00816878020893 - Panosol 62024-03-21
00816878020909 - Panosol 62024-03-21
00816878020916 - Panosol 62024-03-21
00816878020923 - Panosol 62024-03-21
00816878020930 - Panosol 6-3D2024-03-21
00816878020947 - Panosol 6-3D2024-03-21

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.