DURAFIBER Ag 15x15cm 66800572

GUDID 05000223467937

Absorbent, gelling, silver fibrous dressing

SMITH & NEPHEW MEDICAL LIMITED

Exudate-absorbent dressing, hydrophilic-gel, antimicrobial

• Primary Device ID: 05000223467937
• NIH Device Record Key: 42be52ce-87a9-4313-80af-9e1e8907e1e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DURAFIBER Ag 15x15cm
• Version Model Number: 66800572
• Catalog Number: 66800572
• 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	05000223467449 [Primary]
GS1	05000223467937 [Package]; Contains: 05000223467449; Package: Carton [5 Units]; In Commercial Distribution
GS1	05000223467944 [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

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