ComfortFoam Border Heel

GUDID 00714196390905

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 ID00714196390905
NIH Device Record Key30e2ebf8-625a-4b20-9fe5-e041ba70d015
Commercial Distribution StatusIn Commercial Distribution
Brand NameComfortFoam Border Heel
Version Model Number43580
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
GS100714196390905 [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 Heel]

0071419643580443580
0071419639090543580

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