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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• 05000223499396 - RENASYS: 2025-10-01 RENASYS WOUND+ Dressing kit with AIRLOCK Technology with foam, medium
• 05000223499402 - RENASYS: 2025-10-01 RENASYS WOUND+ Dressing kit with AIRLOCK Technology with foam, small
• 05000223504267 - RENASYS: 2025-10-01 RENASYS WOUND+ Dressing kit with AIRLOCK Technology, large
• 05000223504274 - RENASYS: 2025-10-01 RENASYS WOUND+ Dressing kit with AIRLOCK Technology, medium
• 05000223504281 - RENASYS: 2025-10-01 RENASYS WOUND+ Dressing kit with AIRLOCK Technology, small
• 05000223501686 - ALLEVYN™ Ag+: 2025-08-20 ALLEVYN AG+ 3.9IN X 3.9IN
• 05000223501693 - ALLEVYN™ Ag+: 2025-08-20 ALLEVYN AG+ 4.9IN X 4.9IN