HealiAid

Basic Information

• Brand Name: HealiAid
• Primary DI: 04714691850023
• Version / Model: SA001020
• Catalog Number: SA001020
• Company Name: MAXIGEN BIOTECH INC.
• Labeler DUNS: 657266016
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2019-07-23
• Public Version: 2
• Public Version Date: 2020-05-06
• Public Version Status: Update
• Public Device Record Key: 43f6cbf0-a865-44cb-84eb-d74ab043d6c8

Device Description

HealiAid collagen wound dressing is fabricated by native fibrous, absorbable type I collagen, purified from bovine Achilles tendons. HealiAid can greatly enchance and accelerate tissue ingrowth and support bone augmentation. SA001020 size: 10(dia) x 20mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KGN	Dressing, Wound, Collagen	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
45023	Collagen wound matrix dressing	A sterile, bioabsorbable, animal-derived collagen protein matrix designed to provide an occlusive/semi-occlusive cover for wound healing (non-oral) and/or a skin template of living cells (fibroblasts) and/or structural proteins to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration. The device is used for various types of partial- and full-thickness wounds, draining wounds, sores/ulcers, skin lacerations/abrasions, burns, and/or surgical wounds. It may combine collagen with other compounds or supplemental dressing materials (e.g., alginate); it is supplied in various forms. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04714691850023	GS1
Unit of Use	04714691850283	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]