ACTICOAT FLEX3 4" X 8" 66800417

GUDID 00040565125008

Silver coated anti-microbial barrier dressing

SMITH & NEPHEW MEDICAL LIMITED

Wound-nonadherent dressing, absorbent, antimicrobial

• Primary Device ID: 00040565125008
• NIH Device Record Key: 5970ad8f-5d1e-4315-83cc-a41997b776ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACTICOAT FLEX3 4" X 8"
• Version Model Number: 66800417
• Catalog Number: 66800417
• 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	00040565124858 [Primary]
GS1	00040565125008 [Package]; Contains: 00040565124858; Package: Carton [16 Units]; In Commercial Distribution
GS1	30040565125009 [Package]; Package: Case [4 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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