DURAFIBER Ag 10x10cm 66801174

GUDID 05000223480226

Absorbent, gelling, silver fibrous dressing

SMITH & NEPHEW MEDICAL LIMITED

Exudate-absorbent dressing, hydrophilic-gel, antimicrobial

• Primary Device ID: 05000223480226
• NIH Device Record Key: e56c73be-c98a-45a5-8cdd-3d950615e4c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DURAFIBER Ag 10x10cm
• Version Model Number: 66801174
• Catalog Number: 66801174
• Company DUNS: 216344051
• Company Name: SMITH & NEPHEW MEDICAL LIMITED
• 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: 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	05000223467418 [Primary]
GS1	05000223480226 [Package]; Contains: 05000223467418; Package: Carton [10 Units]; In Commercial Distribution
GS1	05000223480233 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-11-02
• Device Publish Date: 2020-10-23

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