MaxioCel Chitosan Wound Dressing

GUDID 00860012016617

The MaxioCel Chitosan Wound Dressing is a soft, sterile, single-use absorbent gelling wound dressing used for absorption of wound exudate. The Maxiocel Chitosan Wound Dressing helps in maintaining a moist, optimal wound healing environment, helps in autolytic debridement, and is easy to remove. The Maxiocel Chitosan Wound Dressing can be kept on the wound site for up to 7 days.

Advamedica Inc.

Chitosan haemostatic agent, professional

• Primary Device ID: 00860012016617
• NIH Device Record Key: 35557099-0c47-424b-92b5-c3de4dd24ba9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MaxioCel Chitosan Wound Dressing
• Version Model Number: MX1010
• Company DUNS: 118526617
• Company Name: Advamedica Inc.
• 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: 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	00860012016617 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212766

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: 2024-05-29
• Device Publish Date: 2024-05-21

On-Brand Devices [MaxioCel Chitosan Wound Dressing]

• 00860012016617: The MaxioCel Chitosan Wound Dressing is a soft, sterile, single-use absorbent gelling wound dres
• 00860012016600: The MaxioCel Chitosan Wound Dressing is a soft, sterile, single-use absorbent gelling wound dres
• 00860008768698: The MaxioCel Chitosan Wound Dressing is a soft, sterile, single-use absorbent gelling wound dres