CovaWound™ Hydrocolloid 10x10 5001010

GUDID 00825439012017

Hydrocolloid Dressing

Covalon Technologies Ltd

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

• Primary Device ID: 00825439012017
• NIH Device Record Key: 3db2242f-fd54-4268-b41e-62251e0326cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CovaWound™ Hydrocolloid 10x10
• Version Model Number: 5001010
• Catalog Number: 5001010
• 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: 10 Centimeter
• Width: 10 Centimeter
• Length: 10 Centimeter
• Width: 10 Centimeter
• Length: 10 Centimeter
• Width: 10 Centimeter
• Length: 10 Centimeter
• Width: 10 Centimeter
• Length: 10 Centimeter
• Width: 10 Centimeter
• Length: 10 Centimeter
• Width: 10 Centimeter
• Length: 10 Centimeter
• Width: 10 Centimeter
• Length: 10 Centimeter
• Width: 10 Centimeter
• Length: 10 Centimeter
• Width: 10 Centimeter
• Length: 10 Centimeter
• Width: 10 Centimeter
• Length: 10 Centimeter
• Width: 10 Centimeter
• Length: 10 Centimeter
• Width: 10 Centimeter
• Length: 10 Centimeter
• Width: 10 Centimeter
• Length: 10 Centimeter
• Width: 10 Centimeter
• Length: 10 Centimeter
• Width: 10 Centimeter
• Length: 10 Centimeter
• Width: 10 Centimeter
• Length: 10 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00825439012000 [Primary]
GS1	00825439012017 [Package]; Contains: 00825439012000; 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: 2023-08-01
• Device Publish Date: 2023-07-24

On-Brand Devices [CovaWound™ Hydrocolloid 10x10]

• 00825439015056: Hydrocolloid Dressing (Thin/Transparent)
• 00825439014936: Hydrocolloid Dressing with Border
• 00825439012017: Hydrocolloid Dressing