THERAFOAM TRRU-6
GUDID 00850014883133
Therafoam Uncoated Wraps 6 Pack
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| Primary Device ID | 00850014883133 |
| NIH Device Record Key | e701172b-abc4-4563-a653-db180645e124 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | THERAFOAM |
| Version Model Number | TRRU-6 |
| Catalog Number | TRRU-6 |
| 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 | 00850014883133 [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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