ACTICOAT 4" X 8" 20201

GUDID 00040565121413

Silver-coated antimicrobial barrier dressing

SMITH & NEPHEW MEDICAL LIMITED

Wound-nonadherent dressing, absorbent, antimicrobial

• Primary Device ID: 00040565121413
• NIH Device Record Key: 276f0902-4248-452d-a756-898b36cb2961
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACTICOAT 4" X 8"
• Version Model Number: 20201
• Catalog Number: 20201
• 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	00040565121413 [Package]; Contains: 05000223449797; Package: Carton [12 Units]; In Commercial Distribution
GS1	05000223449797 [Primary]
GS1	30040565121650 [Package]; Package: Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992221

FDA Product Code

• MGP: Dressing, Wound And Burn, Occlusive

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

Devices Manufactured by SMITH & NEPHEW MEDICAL LIMITED

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• 05000223049249 - IV3000 6X8.5CM-CARTON OF 10: 2023-09-07 Moisture responsive IV catheter dressing
• 05000223049256 - IV3000: 2023-09-07 Moisture responsive catheter dressing. 10cm x 14cm Ctn of 10
• 05000223463113 - OPSITE POST-OP VISIBLE 20X10CM CTN 20: 2023-09-07 Waterproof, bacteria proof dressing with absorbent see through pad
• 00040565122564 - IODOSORB: 2023-09-07 Cadexomer iodine gel. 10g. Ctn of 1 Tube
• 05000223500184 - RENASYS: 2023-09-07 Renasys XL Transparent Film Dressing
• 05000223500207 - RENASYS: 2023-09-07 Renasys-F XL Foam Dressing Kit With Soft Port
• 30040565118254 - IV3000: 2023-09-07 4” x 5” Non-Sterile Bulk