THERAFOAM TRPU-1
GUDID 00854763005839
Therafoam Uncoated Foam 1 Pack
BIODERMIS CORPORATION
Scar management dressing, reusable| Primary Device ID | 00854763005839 |
| NIH Device Record Key | 79bb9b1b-c4d8-402b-be6b-29f372fc8e34 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | THERAFOAM |
| Version Model Number | TRPU-1 |
| Catalog Number | TRPU-1 |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00854763005839 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K991604
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 | 2021-08-23 |
| Device Publish Date | 2021-08-13 |
On-Brand Devices [THERAFOAM]
| 00854763005822 | Therafoam Adhesive Backed Foam 10 Packs per case |
| 00854763005815 | Therafoam Adhesive-Backed Pads (3 pads per pouch) |
| 00854763005808 | Therafoam Adhesive-Backed Pads (1 pad per pouch) |
| 00854763005990 | Therafoam Coated Wraps 1 Pack |
| 00854763005983 | Therafoam Silicone Backed Adhesive Wrap |
| 00854763005853 | Therafoam Uncoated Foam 30 pack |
| 00854763005846 | Therafoam Uncoated Foam 3 Pack |
| 00854763005839 | Therafoam Uncoated Foam 1 Pack |
| 00850014883133 | Therafoam Uncoated Wraps 6 Pack |
| 00850014883126 | Therafoam Uncoated Wraps 1 Pack |
Trademark Results [THERAFOAM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 THERAFOAM 98401604 not registered Live/Pending |
Ther-A-Pedic Associates, Inc. 2024-02-12 |
 THERAFOAM 97823676 not registered Live/Pending |
Everbrands, Inc. 2023-03-05 |
 THERAFOAM 87067839 not registered Dead/Abandoned |
Megalowmart Holdings LLC 2016-06-10 |
 THERAFOAM 85087498 3928599 Live/Registered |
BIODERMIS CORPORATION 2010-07-19 |
 THERAFOAM 76438815 2933621 Live/Registered |
Ther-A-Pedic Associates, Inc. 2002-08-07 |
 THERAFOAM 76381190 2788109 Dead/Cancelled |
NV BIOMEDICAL, INC. 2002-03-11 |
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