EPI-FOAM EPFU-1

GUDID 00854763005754

Epifoam Uncoated Pads (1 pad per pouch).

BIODERMIS CORPORATION

Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable
Primary Device ID00854763005754
NIH Device Record Key555612a9-5031-4917-b55e-6a02315a0440
Commercial Distribution StatusIn Commercial Distribution
Brand NameEPI-FOAM
Version Model NumberEPFU-1
Catalog NumberEPFU-1
Company DUNS809650005
Company NameBIODERMIS CORPORATION
Device Count1
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone702-260-4466
Emailinfo@biodermis.com
Phone702-260-4466
Emailinfo@biodermis.com
Phone702-260-4466
Emailinfo@biodermis.com
Phone702-260-4466
Emailinfo@biodermis.com
Phone702-260-4466
Emailinfo@biodermis.com
Phone702-260-4466
Emailinfo@biodermis.com
Phone702-260-4466
Emailinfo@biodermis.com
Phone702-260-4466
Emailinfo@biodermis.com
Phone702-260-4466
Emailinfo@biodermis.com
Phone702-260-4466
Emailinfo@biodermis.com
Phone702-260-4466
Emailinfo@biodermis.com
Phone702-260-4466
Emailinfo@biodermis.com
Phone702-260-4466
Emailinfo@biodermis.com
Phone702-260-4466
Emailinfo@biodermis.com
Phone702-260-4466
Emailinfo@biodermis.com
Phone702-260-4466
Emailinfo@biodermis.com
Phone702-260-4466
Emailinfo@biodermis.com
Phone702-260-4466
Emailinfo@biodermis.com
Phone702-260-4466
Emailinfo@biodermis.com
Phone702-260-4466
Emailinfo@biodermis.com
Phone702-260-4466
Emailinfo@biodermis.com
Phone702-260-4466
Emailinfo@biodermis.com
Phone702-260-4466
Emailinfo@biodermis.com
Phone702-260-4466
Emailinfo@biodermis.com
Phone702-260-4466
Emailinfo@biodermis.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100854763005754 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MDAElastomer, Silicone, For Scar Management

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-04
Device Publish Date2020-08-27

On-Brand Devices [EPI-FOAM]

00854763005792Uncoated Epifoam Adhesive Wrap (1 wrap) 36"x 11.75"x 0.375"
00854763005785Epifoam Adhesive Wrap (6 sheets per case) 36"x 11.75"x 0.375"
00854763005778Epifoam Adhesive Wrap (1 Wrap ) 36"x 11.75"x 0.375"
00854763005761EpIfoam Silicone-Backed Adhesive Pad (1 pad per pouch)
00854763005754Epifoam Uncoated Pads (1 pad per pouch).
00854763005549Uncoated Epifoam Adhesive Wrap (6 wraps per case) 36"x 11.75"x 0.375"
00854763005532Epifoam Uncoated Pads (30 pads per case).
00854763005525Epifoam Uncoated Pads (3 pads per pouch)
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