MediClear™ Scar 4x4 9000404
GUDID 00825439012277
Self-Adherent Silicone Film Dressing for Scar Care
Covalon Technologies Ltd
Scar management dressing, single-use, non-sterile Scar management dressing, single-use, non-sterile Scar management dressing, single-use, non-sterile Scar management dressing, single-use, non-sterile Scar management dressing, single-use, non-sterile Scar management dressing, single-use, non-sterile Scar management dressing, single-use, non-sterile Scar management dressing, single-use, non-sterile Scar management dressing, single-use, non-sterile Scar management dressing, single-use, non-sterile Scar management dressing, single-use, non-sterile Scar management dressing, single-use, non-sterile Scar management dressing, single-use, non-sterile Scar management dressing, single-use, non-sterile Scar management dressing, single-use, non-sterile Scar management dressing, single-use, non-sterile Scar management dressing, single-use, non-sterile Scar-management dressing, single-use Scar-management dressing, single-use Scar-management dressing, single-use Scar-management dressing, single-use Scar-management dressing, single-use Scar-management dressing, single-use Scar-management dressing, single-use Scar-management dressing, single-use Scar-management dressing, single-use Scar-management dressing, single-use Scar-management dressing, single-use Scar-management dressing, single-use Scar-management dressing, single-use| Primary Device ID | 00825439012277 |
| NIH Device Record Key | a7d01408-044a-40aa-9e6c-b3d3919f10ec |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MediClear™ Scar 4x4 |
| Version Model Number | 9000404 |
| Catalog Number | 9000404 |
| Company DUNS | 206936101 |
| Company Name | Covalon Technologies Ltd |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Device Dimensions
| Length | 4 Centimeter |
| Width | 4 Centimeter |
| Length | 4 Centimeter |
| Width | 4 Centimeter |
| Length | 4 Centimeter |
| Width | 4 Centimeter |
| Length | 4 Centimeter |
| Width | 4 Centimeter |
| Length | 4 Centimeter |
| Width | 4 Centimeter |
| Length | 4 Centimeter |
| Width | 4 Centimeter |
| Length | 4 Centimeter |
| Width | 4 Centimeter |
| Length | 4 Centimeter |
| Width | 4 Centimeter |
| Length | 4 Centimeter |
| Width | 4 Centimeter |
| Length | 4 Centimeter |
| Width | 4 Centimeter |
| Length | 4 Centimeter |
| Width | 4 Centimeter |
| Length | 4 Centimeter |
| Width | 4 Centimeter |
| Length | 4 Centimeter |
| Width | 4 Centimeter |
| Length | 4 Centimeter |
| Width | 4 Centimeter |
| Length | 4 Centimeter |
| Width | 4 Centimeter |
| Length | 4 Centimeter |
| Width | 4 Centimeter |
| Length | 4 Centimeter |
| Width | 4 Centimeter |
| Length | 4 Centimeter |
| Width | 4 Centimeter |
| Length | 4 Centimeter |
| Width | 4 Centimeter |
| Length | 4 Centimeter |
| Width | 4 Centimeter |
| Length | 4 Centimeter |
| Width | 4 Centimeter |
| Length | 4 Centimeter |
| Width | 4 Centimeter |
| Length | 4 Centimeter |
| Width | 4 Centimeter |
| Length | 4 Centimeter |
| Width | 4 Centimeter |
| Length | 4 Centimeter |
| Width | 4 Centimeter |
| Length | 4 Centimeter |
| Width | 4 Centimeter |
| Length | 4 Centimeter |
| Width | 4 Centimeter |
| Length | 4 Centimeter |
| Width | 4 Centimeter |
| Length | 4 Centimeter |
| Width | 4 Centimeter |
| Length | 4 Centimeter |
| Width | 4 Centimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00825439012260 [Primary] |
| GS1 | 00825439012277 [Package] Contains: 00825439012260 Package: Carton [5 Units] In Commercial Distribution |
| GS1 | 10825439012281 [Package] Package: Shipper [10 Units] In Commercial Distribution |
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 | 2023-07-24 |
| Device Publish Date | 2023-07-14 |
Devices Manufactured by Covalon Technologies Ltd
| 00825439011393 - CovaWound™ Silicone 10x10 | 2024-04-16 Self-Adherent Soft Silicone Foam Dressing with Border |
| 00825439011416 - CovaWound™ Silicone 12.5x12.5 | 2024-04-16 Self-Adherent Soft Silicone Foam Dressing with Border |
| 00825439011430 - CovaWound™ Silicone 15x15 | 2024-04-16 Self-Adherent Soft Silicone Foam Dressing with Border |
| 00825439011454 - CovaWound™ Silicone 15x20 | 2024-04-16 Self-Adherent Soft Silicone Foam Dressing with Border |
| 00825439011478 - CovaWound™ Silicone 7.5x7.5 | 2024-04-16 Self-Adherent Soft Silicone Foam Dressing |
| 00825439011515 - CovaWound™ Silicone 12x12 | 2024-04-16 Self-Adherent Soft Silicone Foam Dressing |
| 00825439011553 - CovaWound™ Silicone 15x20 | 2024-04-16 Self-Adherent Soft Silicone Foam Dressing |
| 00825439012055 - CovaWound™ Silicone 18x18 | 2024-04-16 Self-Adherent Soft Silicone Foam Dressing with Border |
Trademark Results [MediClear]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MEDICLEAR 97003933 not registered Live/Pending |
Mediclear LLC 2021-08-31 |
 MEDICLEAR 90638583 not registered Live/Pending |
ActivAge Benefit Advisors, Inc. 2021-04-12 |
 MEDICLEAR 86534208 5223608 Live/Registered |
Covalon Technologies Ltd. 2015-02-13 |
 MEDICLEAR 76278510 2525208 Live/Registered |
THORNE RESEARCH, INC. 2001-07-02 |
 MEDICLEAR 74736835 not registered Dead/Abandoned |
ONE WORLD, INC. 1995-09-27 |
 MEDICLEAR 74585836 1967915 Dead/Cancelled |
MONSANTO COMPANY 1994-10-14 |
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