CovaWound™ Hydrocolloid 5x10 5000510
GUDID 00825439011997
Hydrocolloid Dressing
Covalon Technologies Ltd
Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial| Primary Device ID | 00825439011997 |
| NIH Device Record Key | 336d2e33-31f4-4975-b5d9-bf64d0be3cf8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CovaWound™ Hydrocolloid 5x10 |
| Version Model Number | 5000510 |
| Catalog Number | 5000510 |
| 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 | 5 Centimeter |
| Width | 10 Centimeter |
| Length | 5 Centimeter |
| Width | 10 Centimeter |
| Length | 5 Centimeter |
| Width | 10 Centimeter |
| Length | 5 Centimeter |
| Width | 10 Centimeter |
| Length | 5 Centimeter |
| Width | 10 Centimeter |
| Length | 5 Centimeter |
| Width | 10 Centimeter |
| Length | 5 Centimeter |
| Width | 10 Centimeter |
| Length | 5 Centimeter |
| Width | 10 Centimeter |
| Length | 5 Centimeter |
| Width | 10 Centimeter |
| Length | 5 Centimeter |
| Width | 10 Centimeter |
| Length | 5 Centimeter |
| Width | 10 Centimeter |
| Length | 5 Centimeter |
| Width | 10 Centimeter |
| Length | 5 Centimeter |
| Width | 10 Centimeter |
| Length | 5 Centimeter |
| Width | 10 Centimeter |
| Length | 5 Centimeter |
| Width | 10 Centimeter |
| Length | 5 Centimeter |
| Width | 10 Centimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00825439011980 [Primary] |
| GS1 | 00825439011997 [Package] Contains: 00825439011980 Package: Carton [10 Units] In Commercial Distribution |
FDA Product Code
| NAD | Dressing, Wound, Occlusive |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-07 |
| Device Publish Date | 2023-07-28 |
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 [CovaWound]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COVAWOUND 86534190 5223607 Live/Registered |
Covalon Technologies Ltd. 2015-02-13 |
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