ACTICOAT FLEX3 4" X 48" 66800434

GUDID 00040565125060

Silver-coated antimicrobial barrier dressing

SMITH & NEPHEW MEDICAL LIMITED

Wound-nonadherent dressing, absorbent, antimicrobial

• Primary Device ID: 00040565125060
• NIH Device Record Key: f2306f39-5ed7-4e5d-acbe-21351e759795
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACTICOAT FLEX3 4" X 48"
• Version Model Number: 66800434
• Catalog Number: 66800434
• 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	00040565124919 [Primary]
GS1	00040565125060 [Package]; Contains: 00040565124919; Package: Carton [6 Units]; In Commercial Distribution
GS1	30040565125061 [Package]; Package: Case [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083113

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: 2020-07-24
• Device Publish Date: 2020-07-16

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