BasaDrox Rx Wound Gel

GUDID 00315455956834

BasaDrox Rx Wound Gel is a wound dressing hydrogel that helps maintain a moist wound environment that is conducive to healing by either absorbing or donating moisture and wound exudates.

ALVIX LABORATORIES, LLC

Wound hydrogel dressing, non-sterile
Primary Device ID00315455956834
NIH Device Record Keydbc373b6-a258-4261-b3db-9da8d782dbc8
Commercial Distribution StatusIn Commercial Distribution
Brand NameBasaDrox Rx Wound Gel
Version Model NumberFP1019-20
Company DUNS962445925
Company NameALVIX LABORATORIES, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100315455956834 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRODressing, Wound, Drug

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-18
Device Publish Date2020-03-10

Devices Manufactured by ALVIX LABORATORIES, LLC

00315455956612 - KamDoy Rx Skin Emulsion2020-05-25 KamDoy Rx Skin Emulsion is indicated as a prescription topical skin care emulsion to manage and relieve the burning and itching
00315455956834 - BasaDrox Rx Wound Gel2020-03-18BasaDrox Rx Wound Gel is a wound dressing hydrogel that helps maintain a moist wound environment that is conducive to healing by either absorbing or donating moisture and wound exudates.
00315455956834 - BasaDrox Rx Wound Gel2020-03-18 BasaDrox Rx Wound Gel is a wound dressing hydrogel that helps maintain a moist wound environment that is conducive to healing by

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