N/A 66801692

GUDID 00040565127132

Foam Wound Dressing

SMITH & NEPHEW MEDICAL LIMITED

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• Primary Device ID: 00040565127132
• NIH Device Record Key: 0da6b49c-9cce-4192-ac80-88c0c623a84b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: 66801692
• Catalog Number: 66801692
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00040565127132 [Primary]
GS1	30040565127133 [Package]; Package: Case [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142979

FDA Product Code

• OMP: Negative Pressure Wound Therapy Powered Suction Pump

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-01-25
• Device Publish Date: 2016-09-20

On-Brand Devices [N/A]

• 30040565124224: NPWT Antimicrobial Large Gauze Roll
• 00040565127132: Foam Wound Dressing
• 30040565127126: Antimicrobial Gauze