CovaWound™ Alginate 15x15 3001515

GUDID 00825439013694

Alginate 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 Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial

• Primary Device ID: 00825439013694
• NIH Device Record Key: a0c93e31-2d6f-4a60-b702-66e3f16295f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CovaWound™ Alginate 15x15
• Version Model Number: 3001515
• Catalog Number: 3001515
• 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: true
• 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: 15 Centimeter
• Width: 15 Centimeter
• Length: 15 Centimeter
• Width: 15 Centimeter
• Length: 15 Centimeter
• Width: 15 Centimeter
• Length: 15 Centimeter
• Width: 15 Centimeter
• Length: 15 Centimeter
• Width: 15 Centimeter
• Length: 15 Centimeter
• Width: 15 Centimeter
• Length: 15 Centimeter
• Width: 15 Centimeter
• Length: 15 Centimeter
• Width: 15 Centimeter
• Length: 15 Centimeter
• Width: 15 Centimeter
• Length: 15 Centimeter
• Width: 15 Centimeter
• Length: 15 Centimeter
• Width: 15 Centimeter
• Length: 15 Centimeter
• Width: 15 Centimeter
• Length: 15 Centimeter
• Width: 15 Centimeter
• Length: 15 Centimeter
• Width: 15 Centimeter
• Length: 15 Centimeter
• Width: 15 Centimeter
• Length: 15 Centimeter
• Width: 15 Centimeter
• Length: 15 Centimeter
• Width: 15 Centimeter
• Length: 15 Centimeter
• Width: 15 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
• 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	00825439013687 [Primary]
GS1	00825439013694 [Package]; Contains: 00825439013687; Package: Carton [5 Units]; In Commercial Distribution

FDA Product Code

• NAC: Dressing, Wound, Hydrophilic

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: 2023-08-08
• Device Publish Date: 2023-07-31

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• 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