HealiAid Collagen Wound Dressing

GUDID 04714691221052

MAXIGEN BIOTECH INC.

Collagen wound matrix dressing

• Primary Device ID: 04714691221052
• NIH Device Record Key: f49f182c-93a6-4b12-bb9a-2c696f95a994
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HealiAid Collagen Wound Dressing
• Version Model Number: HA203005
• Company DUNS: 657266016
• Company Name: MAXIGEN BIOTECH 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: 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	04714691221052 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223126

FDA Product Code

• KGN: Wound Dressing With Animal-Derived Material(S)

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: 2024-11-26
• Device Publish Date: 2024-11-18

On-Brand Devices [HealiAid Collagen Wound Dressing]

• 04714691221137: HA101030
• 04714691221120: HA505030
• 04714691221113: HA405030
• 04714691221106: HA303030
• 04714691221090: HA204030
• 04714691221083: HA101005
• 04714691221076: HA304005
• 04714691221069: HA253005
• 04714691221052: HA203005
• 04714691221045: HA152005