ComfortFoam/Ag Border

GUDID 00714196486608

DERMARITE INDUSTRIES LLC

Exudate-absorbent dressing, non-gel, antimicrobial
Primary Device ID00714196486608
NIH Device Record Key7815f9b3-bbdf-469e-90ba-0331c2448d40
Commercial Distribution StatusIn Commercial Distribution
Brand NameComfortFoam/Ag Border
Version Model Number48660
Company DUNS883925562
Company NameDERMARITE INDUSTRIES LLC
Device Count10
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
GS100714196486608 [Primary]
GS101714196486607 [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

On-Brand Devices [ComfortFoam/Ag Border]

0071419648660848660
0071419648440648440
0071419648220448220
0071419639112448660
0071419639110048440
0071419639108748220

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