Architect Fx

Basic Information

• Brand Name: Architect Fx
• Primary DI: 00854780005546
• Version / Model: HMT100Fx
• Catalog Number: HMT100Fx
• Company Name: HARBOR MEDTECH, INC.
• Labeler DUNS: 016615914
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-02-24
• Public Version: 1
• Public Version Date: 2026-03-04
• Public Version Status: New
• Public Device Record Key: d96a5ff7-0d36-47ca-be09-7637cd7ac0a0

Device Description

Collagen Wound Matrix

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
47935	Skin xenograft	Skin tissue intended for transplantation that is harvested from an animal donor (e.g., porcine source) and implanted in a human recipient. The tissue is used to temporarily replace skin (for a few days) typically lost due to extensive wounds and burns, when sufficient tissue from the patient or skin banks is not available, to cover and protect the lesions and reduce fluid loss. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00854780005546	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Area/Surface Area	100	Square centimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 25 Degrees Celsius