DURAFIBER Ag 10x12cm 66800571

GUDID 05000223467906

Absorbent gelling silver fibrous dressing

SMITH & NEPHEW MEDICAL LIMITED

Exudate-absorbent dressing, hydrophilic-gel, antimicrobial

• Primary Device ID: 05000223467906
• NIH Device Record Key: 36bd1385-9ed2-4bed-bf0e-382598943f48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DURAFIBER Ag 10x12cm
• Version Model Number: 66800571
• Catalog Number: 66800571
• Company DUNS: 216344051
• Company Name: SMITH & NEPHEW MEDICAL LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05000223467890 [Primary]
GS1	05000223467906 [Package]; Contains: 05000223467890; Package: Carton [10 Units]; In Commercial Distribution
GS1	05000223467913 [Package]; Package: Case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161289

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-07-22
• Device Publish Date: 2020-09-18

Devices Manufactured by SMITH & NEPHEW MEDICAL LIMITED

• 05000223504151 - BIOBRANE: 2025-03-11 BIOBRANE DRESSING - SMALL GLOVE US
• 05000223504168 - BIOBRANE: 2025-03-11 BIOBRANE DRESSING - MEDIUM GLOVE US
• 05000223504175 - BIOBRANE: 2025-03-11 BIOBRANE DRESSING - LARGE GLOVE US
• 05000223504182 - BIOBRANE: 2025-03-11 BIOBRANE DRESSING - PEDIATRIC GLOVE US
• 05000223504113 - BIOBRANE: 2025-03-10 BIOBRANE DRESSING 5.1INX5.1IN CTN 5 US
• 05000223504137 - BIOBRANE: 2025-03-10 BIOBRANE DRESSING 9.8INX15IN CTN 1 US
• 05000223504144 - BIOBRANE: 2025-03-10 BIOBRANE DRESSING 15INX19.7IN CTN 1 US
• 05000223504120 - BIOBRANE: 2025-03-07 BIOBRANE DRESSING 5.1INX15IN CTN 5 (US)