AQUACEL AG 420128

GUDID 00768455145621

AQUACEL AG WSF 1X45CM STER(1X5PK)US

CONVATEC, PURCHASING DEPARTMENT

Exudate-absorbent dressing, hydrophilic-gel, antimicrobial, sterile

• Primary Device ID: 00768455145621
• NIH Device Record Key: 5ecf6193-ffb3-4839-86e3-3b549bba1560
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AQUACEL AG
• Version Model Number: 420128
• Catalog Number: 420128
• Company DUNS: 809784593
• Company Name: CONVATEC, PURCHASING DEPARTMENT
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Width: 45 Centimeter
• Width: 45 Centimeter
• Width: 45 Centimeter
• Width: 45 Centimeter
• Width: 45 Centimeter
• Width: 45 Centimeter
• Width: 45 Centimeter
• Width: 45 Centimeter
• Width: 45 Centimeter
• Width: 45 Centimeter
• Width: 45 Centimeter
• Width: 45 Centimeter
• Width: 45 Centimeter
• Width: 45 Centimeter
• Width: 45 Centimeter
• Width: 45 Centimeter
• Width: 45 Centimeter
• Width: 45 Centimeter
• Width: 45 Centimeter
• Width: 45 Centimeter
• Width: 45 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00768455118175 [Package]; Package: Carton [5 Units]; In Commercial Distribution
GS1	00768455145621 [Primary]
GS1	10768455118172 [Package]; Contains: 00768455118175; Package: Case [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080383

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-22

On-Brand Devices [AQUACEL AG]

• 00768455145621: AQUACEL AG WSF 1X45CM STER(1X5PK)US
• 10768455106742: AQUACEL AG WSF 2X45CM (1X5PK)STER NAI
• 00768455125104: AQUACEL AG SCD DRS 9X30CM (1X10PK) NAI
• 00768455124305: AQUACEL AG SCD DRS 9X10CM (1X10PK) US
• 00768455124299: AQUACEL AG SCD DRS 9X25CM (1X10PK) US
• 00768455124282: AQUACEL AG SCD DRS 9X15CM (1X10PK) US
• 00768455124275: AQUACEL AG SCD DRS 9X35CM (1X10PK) US