DermaBlue+Foam Healogics by DermaRite

GUDID 00714196941152

DERMARITE INDUSTRIES LLC

Exudate-absorbent dressing, non-gel, antimicrobial
Primary Device ID00714196941152
NIH Device Record Key79e404f9-b7c7-4165-8667-9c556501c0cd
Commercial Distribution StatusIn Commercial Distribution
Brand NameDermaBlue+Foam Healogics by DermaRite
Version Model Number94115
Company DUNS883925562
Company NameDERMARITE INDUSTRIES LLC
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100714196941152 [Primary]
GS101714196941151 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRODressing, Wound, Drug

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-09
Device Publish Date2020-09-01

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