HealiAid Dental Collagen Wound Dressing

GUDID 04714691850290

MAXIGEN BIOTECH INC.

General oral wound dressing, animal-derived

• Primary Device ID: 04714691850290
• NIH Device Record Key: 12fc8970-1b2b-47fa-b272-fb3da9516c09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HealiAid Dental Collagen Wound Dressing
• Version Model Number: HAD001520
• Company DUNS: 657266016
• Company Name: MAXIGEN BIOTECH INC.
• Device Count: 10
• 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	04714691213170 [Primary]
GS1	04714691213484 [Primary]
GS1	04714691850290 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230529

FDA Product Code

• OLR: Oral Wound Dressing

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: 2024-08-05
• Device Publish Date: 2024-07-26

On-Brand Devices [HealiAid Dental Collagen Wound Dressing]

• 04714691213125: HAD001520
• 04714691213118: HAD001020
• 04714691213101: HAD100100
• 04714691213095: HAD505030
• 04714691213088: HADB304030
• 04714691213071: HAD204030
• 04714691213064: HADB253030
• 04714691213057: HADB152030
• 04714691213040: HAD304005
• 04714691213033: HAD253005
• 04714691213026: HAD203005
• 04714691213019: HAD152005
• 04714691213460: HAD001020
• 04714691850290: HAD001520
• 04714691850283: HAD001020