CovaWound Alginate Ag 5x5cm

GUDID 00825439012154

Alginate dressing with silver

Covalon Technologies Ltd

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

• Primary Device ID: 00825439012154
• NIH Device Record Key: 86ce8520-9285-45d1-a058-445c7e7ee76d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CovaWound Alginate Ag 5x5cm
• Version Model Number: 3100505
• Company DUNS: 206936101
• Company Name: Covalon Technologies Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• 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: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 5 Centimeter
• Width: 5 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Length: 5 Centimeter
• Width: 5 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00825439012147 [Primary]
GS1	00825439012154 [Package]; Contains: 00825439012147; Package: Carton [10 Units]; In Commercial Distribution
GS1	10825439012229 [Package]; Package: Shipper [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071442

FDA Product Code

• FRO: Dressing, Wound, Drug

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: 2022-12-09
• Device Publish Date: 2022-12-01

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