NuForra

Basic Information

• Brand Name: NuForra
• Primary DI: 00198715991772
• Version / Model: NUF-300
• Company Name: KAIROS BIOSCIENCES LLC
• Labeler DUNS: 132083159
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-07
• Public Version: 3
• Public Version Date: 2025-09-15
• Public Version Status: Update
• Public Device Record Key: 4de19694-f286-458f-873e-b961cc550fa2
• Distribution End Date: 2025-09-14

Device Description

NuForra Surgical Wound Care consists of fibrous, Type I bovine collagen intended for the management of surgical wounds and a wide range of acute and chronic wounds. NuForra is designed to support a moist wound environment to promote natural healing. Indications for Use: Indicated for surgical wounds, partial- and full-thickness wounds, pressure ulcers (Stages I-IV), venous ulcers, ulcers caused by mixed vascular etiologies, venous stasis ulcers, diabetic ulcers, first- and second-degree burns, cuts, and abrasions. NuForra is suitable for application to surgical incision sites and wounds.

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
48124	Exudate-absorbent dressing, non-gel, antimicrobial	A wound covering intended to absorb exudates and blood from a wound (e.g., ulcers, burns, surgical wounds, lacerations, abrasions, and/or percutaneous device wounds), and that contains an antimicrobial agent [e.g., silver (Ag), chlorhexidine gluconate (CHG)]. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudate. It is intended to create a moist wound-healing environment and/or protect wounds from external contamination by microorganisms from the periwound skin. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, or powder. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00198715991772	GS1

Customer Contacts

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