ACTICOAT FLEX7 2.5CMX60CM CTN OF 5 66800545

GUDID 00040565125282

Silver coated anti-microbial barrier dressing

SMITH & NEPHEW MEDICAL LIMITED

Wound-nonadherent dressing, absorbent, antimicrobial

• Primary Device ID: 00040565125282
• NIH Device Record Key: 78005e5f-dda7-4b93-8ab6-9ecd740ecd3b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACTICOAT FLEX7 2.5CMX60CM CTN OF 5
• Version Model Number: 66800545
• Catalog Number: 66800545
• Company DUNS: 216344051
• Company Name: SMITH & NEPHEW MEDICAL LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	00040565125268 [Package]; Contains: 00040565125275; Package: Carton 66800544 [5 Units]; In Commercial Distribution
GS1	00040565125275 [Primary]
GS1	00040565125282 [Package]; Contains: 00040565125275; Package: Carton [5 Units]; In Commercial Distribution
GS1	30040565125269 [Package]; Contains: 00040565125268; Package: Case 66800544 [10 Units]; In Commercial Distribution
GS1	30040565125283 [Package]; Package: Case [10 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: 2020-05-25
• Device Publish Date: 2020-05-15

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