EPI-DERM EDGTNT-1116
GUDID 00852260000555
TNT Large Sheet, 11" x 15.75" (28 x 40 x 0.09cm), 1 Large Sheet
BIODERMIS CORPORATION
Scar management dressing, reusable| Primary Device ID | 00852260000555 |
| NIH Device Record Key | 4658da52-3655-4710-a202-2fc2b9a3418f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EPI-DERM |
| Version Model Number | EDGTNT-1116 |
| Catalog Number | EDGTNT-1116 |
| Company DUNS | 809650005 |
| Company Name | BIODERMIS CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
| Phone | 702-260-4466 |
| info@biodermis.com | |
| Phone | 702-260-4466 |
| info@biodermis.com | |
| Phone | 702-260-4466 |
| info@biodermis.com | |
| Phone | 702-260-4466 |
| info@biodermis.com | |
| Phone | 702-260-4466 |
| info@biodermis.com | |
| Phone | 702-260-4466 |
| info@biodermis.com | |
| Phone | 702-260-4466 |
| info@biodermis.com | |
| Phone | 702-260-4466 |
| info@biodermis.com | |
| Phone | 702-260-4466 |
| info@biodermis.com | |
| Phone | 702-260-4466 |
| info@biodermis.com | |
| Phone | 702-260-4466 |
| info@biodermis.com | |
| Phone | 702-260-4466 |
| info@biodermis.com | |
| Phone | 702-260-4466 |
| info@biodermis.com | |
| Phone | 702-260-4466 |
| info@biodermis.com | |
| Phone | 702-260-4466 |
| info@biodermis.com | |
| Phone | 702-260-4466 |
| info@biodermis.com | |
| Phone | 702-260-4466 |
| info@biodermis.com | |
| Phone | 702-260-4466 |
| info@biodermis.com | |
| Phone | 702-260-4466 |
| info@biodermis.com | |
| Phone | 702-260-4466 |
| info@biodermis.com | |
| Phone | 702-260-4466 |
| info@biodermis.com | |
| Phone | 702-260-4466 |
| info@biodermis.com | |
| Phone | 702-260-4466 |
| info@biodermis.com | |
| Phone | 702-260-4466 |
| info@biodermis.com | |
| Phone | 702-260-4466 |
| info@biodermis.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00852260000555 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K003948
FDA Product Code
| MDA | Elastomer, Silicone, For Scar Management |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-04 |
| Device Publish Date | 2020-08-27 |
On-Brand Devices [EPI-DERM]
| 00854763005877 | Natural Fabric Standard sheet 4.7" x 5.7", 6 Sheets |
| 00854763005860 | TNT Standard sheet 4.7" x 5.7", 6 Sheets |
| 00854763005006 | Fabric Backed Silicone Strip 1.4" x 6.0". 2 Strips |
| 00852260000944 | Areopexy 2.75" OD x .75 ID x 5.90" L (6.9cm OD x 1.9cm ID) 5 Pair |
| 00852260000937 | Areopexy 2.75" OD x .75 ID x 5.90" L (6.9cm OD x 1.9cm ID) 1 Pair |
| 00852260000920 | TNT EpiTab Squares 30-Pack 1.25" x 1.25" (3 x 3 cm) |
| 00852260000913 | TNT EpiTab Circles 30-Pack 1.90 cm Diam |
| 00852260000906 | TNT Areopexy 2.75" OD x .75 ID x 5.90", 5 Pair |
| 00852260000890 | TNT Areopexy 2.75" OD x .75 ID x 5.90", 1 Pair |
| 00852260000876 | Natural Fabric Mastopexy-L/R 12.6" x 3.8" (32. x 9.63 cm). 5 Pair |
| 00852260000715 | Areola Circles 3" x .75" (7.60 x 1.90 cm). 1 Pair |
| 00852260000708 | Areola Circles 3" x .75" (7.60 x 1.90 cm). 5 Pair |
| 00852260000692 | TNT Areola Circle, 3" x 0.75", (7.60 OD x 1.90 ID x 0.09cm), 1 Pair |
| 00852260000685 | TNT Areola Circle, 3" x 0.75", (7.60 OD x 1.90 ID x 0.09cm), 5 Pair |
| 00852260000678 | C-Strip 1.4" x 6.0" (3.6 x 15 cm). 1 C-Strip |
| 00852260000661 | Strip 1.4" x 11.5" (3.6 x 29 cm) 1 Pair |
| 00852260000654 | Large sheet 11" x 15.75" (28 x 40 cm). 1 Sheet |
| 00852260000647 | Patch 2 x 2.5 in. (5 x 6 cm). 1 Pair |
| 00852260000630 | Standard sheet 4.7 x 5.7 in. (12 x 14.5 cm). 1 Sheet |
| 00852260000623 | Standard sheet 4.7 x 5.7 in. (12 x 14.5 cm). 5 Sheets |
| 00852260000616 | C-Strip 1.4" x 6.0" (3.6 x 15 cm). 5 C-Strips |
| 00852260000609 | Strip 1.4" x 11.5" (3.6 x 29 cm) 5 Pair |
| 00852260000593 | Large sheet 11" x 15.75" (28 x 40 cm). 5 Sheets |
| 00852260000586 | Patch 2 x 2.5 in. (5 x 6 cm). 5 Pair |
| 00852260000579 | TNT C-Strip, 1.4" x 6.0", (3.6 x 15 x 0.09cm), 1 C-Strip |
| 00852260000562 | TNT, Strip, 1.4" x 11.5", (3.60 x 29.0 x 0.09cm) , 1 Pair |
| 00852260000555 | TNT Large Sheet, 11" x 15.75" (28 x 40 x 0.09cm), 1 Large Sheet |
| 00852260000548 | TNT Patch, 2" x 2.5", (5.0 x 6.0 x 0.09cm), 1 Pair |
| 00852260000531 | TNT Standard Sheet, 4.7" x 5.7", (12 x 14.5 x 0.09cm), 1 Sheet |
| 00852260000524 | TNT Standard Sheet, 4.5" x 5.7", (12 x 14.5 x 0.09cm), 5 Pack |
| 00852260000517 | TNT C-Strip, 1.4" x 6.0", (3.6 x 15 x 0.09cm), 5 Pack |
| 00852260000500 | TNT Strip, 1.4" x 11.5", (3.60 x 29.0 x 0.09cm), 5 Pack |
| 00852260000494 | TNT Large Sheet, 11" x 15.75", (28 x 40 x 0.09cm), 5 Pack |
| 00852260000487 | TNT, Patch 2" x 2.5", (5.0 x 6.0 x 0.09cm), 5 Pack |
| 00852260000470 | Mastopexy-L/R 12.6 x 3.8 in. (32. x 9.63 cm). 1 Pair |
| 00852260000463 | Mastopexy-L/R 12.6 x 3.8 in. (32. x 9.63 cm). 5 Pair |
| 00852260000456 | TNT Mastopexy-L/R 12.6" x 3.8", (32 x 9.63 x 0.09 cm), 1 Pair |
| 00852260000449 | TNT Mastopexy-L/R 12.6" x 3.8", (32 x 9.63 x 0.09 cm), 5 Pair |
| 00852260000425 | Natural Fabric Areola Circles 3" x .75". (7.60 x 1.90cm). 1 Pair |
| 00852260000418 | Natural Fabric Areola Circles 3" x .75" (7.60 x 1.90cm). 5 Pair |
| 00852260000401 | Natural Fabric C-Strip 1.4" x 6.0" (3.6 x 15 cm), 1 C-Strip |
| 00852260000395 | Natural Fabric Strip 1.4" x 11.5" (3.6 x 29 cm) 1 Pair |
| 00852260000388 | Natural Fabric Large sheet 11" x 15.25" (28 x 39 cm). 1 Large Sheet |
| 00852260000371 | Natural Fabric Patch 2" x 2.5" (5 x 6 cm). 1 Pair |
| 00852260000364 | Natural Fabric Standard sheet 4.7" x 5.7" (12 x 14.5 cm). 1 Sheet |
| 00852260000357 | Natural Fabric Standard sheet 4.7" x 5.7" (12 x 14.5 cm). 5 Sheets |
| 00852260000340 | Natural Fabric C-Strip 1.4" x 6.0" (3.6 x 15 cm), 5 C-Strips |
| 00852260000333 | Natural Fabric Strip 1.4" x 11.5" (3.6 x 29 cm) 5 Pair |
| 00852260000326 | Natural Fabric Large sheet 11" x 15.25" (28 x 39 cm). 5 Large Sheets |
| 00852260000319 | Natural 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 76421997 not registered Dead/Abandoned |
DREAMOUS CORPORATION USA 2002-06-17 |
 EPI-DERM 76001047 2440827 Live/Registered |
BIODERMIS CORPORATION 2000-03-13 |
 EPI-DERM 74449378 not registered Dead/Abandoned |
Biodermis 1993-10-22 |
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