ComfortFoam Border Lite

GUDID 00714196390943

DERMARITE INDUSTRIES LLC

Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial Exudate-absorbent dressing, non-gel, non-antimicrobial
Primary Device ID00714196390943
NIH Device Record Key68bd8b97-e4bd-41bb-818c-d9d4c41e3394
Commercial Distribution StatusIn Commercial Distribution
Brand NameComfortFoam Border Lite
Version Model Number47330
Company DUNS883925562
Company NameDERMARITE INDUSTRIES LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS100714196390943 [Primary]

FDA Product Code

NADDressing, Wound, Occlusive

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-17
Device Publish Date2021-09-09

On-Brand Devices [ComfortFoam Border Lite]

0071419647450647440
0071419647330147330
0071419647220547220
0071419639096747440
0071419639094347330
0071419639092947220

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