Keramatrix

Basic Information

• Brand Name: Keramatrix
• Primary DI: 00850072068879
• Version / Model: KM-0505
• Catalog Number: KM-0505
• Company Name: Biowound Solutions, Inc.
• Labeler DUNS: 135705894
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-18
• Public Version: 1
• Public Version Date: 2025-06-26
• Public Version Status: New
• Public Device Record Key: 956018d7-ce10-46ad-b0a7-ff8077e969c9

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: 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
FRO	Dressing, Wound, Drug	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
58867	Keratin dressing	A sterile keratin protein compound, animal-derived, intended to be applied to dry skin wounds to provide a moist and keratin-rich environment to promote autolytic debridement and healing. It is intended for various types of dry wounds including stage II and III pressure ulcers, arterial ulcers, venous stasis ulcers, surgical wounds, and wounds resulting from Epidermolysis Bullosa. It is available in the form of a gel. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850072068879	GS1