EPI-DERM FLP-1

GUDID 00852260000128

Natural Fabric Areopexy 2.75" OD x .75 ID x 5.90" L (6.9cm OD x 1.9cm ID) 1 Pair

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 ID00852260000128
NIH Device Record Key59dbe4b8-2ecb-4191-a664-80be0d4cb35b
Commercial Distribution StatusIn Commercial Distribution
Brand NameEPI-DERM
Version Model NumberFLP-1
Catalog NumberFLP-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
GS100852260000128 [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-DERM]

00854763005877Natural Fabric Standard sheet 4.7" x 5.7", 6 Sheets
00854763005860TNT Standard sheet 4.7" x 5.7", 6 Sheets
00854763005006Fabric Backed Silicone Strip 1.4" x 6.0". 2 Strips
00852260000944Areopexy 2.75" OD x .75 ID x 5.90" L (6.9cm OD x 1.9cm ID) 5 Pair
00852260000937Areopexy 2.75" OD x .75 ID x 5.90" L (6.9cm OD x 1.9cm ID) 1 Pair
00852260000920TNT EpiTab Squares 30-Pack 1.25" x 1.25" (3 x 3 cm)
00852260000913TNT EpiTab Circles 30-Pack 1.90 cm Diam
00852260000906TNT Areopexy 2.75" OD x .75 ID x 5.90", 5 Pair
00852260000890TNT Areopexy 2.75" OD x .75 ID x 5.90", 1 Pair
00852260000876Natural Fabric Mastopexy-L/R 12.6" x 3.8" (32. x 9.63 cm). 5 Pair
00852260000715Areola Circles 3" x .75" (7.60 x 1.90 cm). 1 Pair
00852260000708Areola Circles 3" x .75" (7.60 x 1.90 cm). 5 Pair
00852260000692TNT Areola Circle, 3" x 0.75", (7.60 OD x 1.90 ID x 0.09cm), 1 Pair
00852260000685TNT Areola Circle, 3" x 0.75", (7.60 OD x 1.90 ID x 0.09cm), 5 Pair
00852260000678C-Strip 1.4" x 6.0" (3.6 x 15 cm). 1 C-Strip
00852260000661Strip 1.4" x 11.5" (3.6 x 29 cm) 1 Pair
00852260000654Large sheet 11" x 15.75" (28 x 40 cm). 1 Sheet
00852260000647Patch 2 x 2.5 in. (5 x 6 cm). 1 Pair
00852260000630Standard sheet 4.7 x 5.7 in. (12 x 14.5 cm). 1 Sheet
00852260000623Standard sheet 4.7 x 5.7 in. (12 x 14.5 cm). 5 Sheets
00852260000616C-Strip 1.4" x 6.0" (3.6 x 15 cm). 5 C-Strips
00852260000609Strip 1.4" x 11.5" (3.6 x 29 cm) 5 Pair
00852260000593Large sheet 11" x 15.75" (28 x 40 cm). 5 Sheets
00852260000586Patch 2 x 2.5 in. (5 x 6 cm). 5 Pair
00852260000579TNT C-Strip, 1.4" x 6.0", (3.6 x 15 x 0.09cm), 1 C-Strip
00852260000562TNT, Strip, 1.4" x 11.5", (3.60 x 29.0 x 0.09cm) , 1 Pair
00852260000555TNT Large Sheet, 11" x 15.75" (28 x 40 x 0.09cm), 1 Large Sheet
00852260000548TNT Patch, 2" x 2.5", (5.0 x 6.0 x 0.09cm), 1 Pair
00852260000531TNT Standard Sheet, 4.7" x 5.7", (12 x 14.5 x 0.09cm), 1 Sheet
00852260000524TNT Standard Sheet, 4.5" x 5.7", (12 x 14.5 x 0.09cm), 5 Pack
00852260000517TNT C-Strip, 1.4" x 6.0", (3.6 x 15 x 0.09cm), 5 Pack
00852260000500TNT Strip, 1.4" x 11.5", (3.60 x 29.0 x 0.09cm), 5 Pack
00852260000494TNT Large Sheet, 11" x 15.75", (28 x 40 x 0.09cm), 5 Pack
00852260000487TNT, Patch 2" x 2.5", (5.0 x 6.0 x 0.09cm), 5 Pack
00852260000470Mastopexy-L/R 12.6 x 3.8 in. (32. x 9.63 cm). 1 Pair
00852260000463Mastopexy-L/R 12.6 x 3.8 in. (32. x 9.63 cm). 5 Pair
00852260000456TNT Mastopexy-L/R 12.6" x 3.8", (32 x 9.63 x 0.09 cm), 1 Pair
00852260000449TNT Mastopexy-L/R 12.6" x 3.8", (32 x 9.63 x 0.09 cm), 5 Pair
00852260000425Natural Fabric Areola Circles 3" x .75". (7.60 x 1.90cm). 1 Pair
00852260000418Natural Fabric Areola Circles 3" x .75" (7.60 x 1.90cm). 5 Pair
00852260000401Natural Fabric C-Strip 1.4" x 6.0" (3.6 x 15 cm), 1 C-Strip
00852260000395Natural Fabric Strip 1.4" x 11.5" (3.6 x 29 cm) 1 Pair
00852260000388Natural Fabric Large sheet 11" x 15.25" (28 x 39 cm). 1 Large Sheet
00852260000371Natural Fabric Patch 2" x 2.5" (5 x 6 cm). 1 Pair
00852260000364Natural Fabric Standard sheet 4.7" x 5.7" (12 x 14.5 cm). 1 Sheet
00852260000357Natural Fabric Standard sheet 4.7" x 5.7" (12 x 14.5 cm). 5 Sheets
00852260000340Natural Fabric C-Strip 1.4" x 6.0" (3.6 x 15 cm), 5 C-Strips
00852260000333Natural Fabric Strip 1.4" x 11.5" (3.6 x 29 cm) 5 Pair
00852260000326Natural Fabric Large sheet 11" x 15.25" (28 x 39 cm). 5 Large Sheets
00852260000319Natural Fabric Patch 2" x 2.5" (5 x 6 cm). 5 Pair

Trademark Results [EPI-DERM]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EPI-DERM
EPI-DERM
76421997 not registered Dead/Abandoned
DREAMOUS CORPORATION USA
2002-06-17
EPI-DERM
EPI-DERM
76001047 2440827 Live/Registered
BIODERMIS CORPORATION
2000-03-13
EPI-DERM
EPI-DERM
74449378 not registered Dead/Abandoned
Biodermis
1993-10-22
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