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510(k) Data Aggregation
K Number
K220759Device Name
Armis VeriCyn Wound Wash
Manufacturer
Armis Biopharma, Inc.
Date Cleared
2023-05-25
(436 days)
Product Code
FQH, FRO
Regulation Number
880.5475Why did this record match?
Applicant Name (Manufacturer) :
Armis Biopharma, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Armis VeriCyn® Wound Wash is to be used with a lavage system to create mechanical movement at the wound surface by delivery of a solution and is indicated for use in cleansing and removal of foreign material including microorganisms and debris from wounds (such as stage I-IV pressure ulcers, diabetic foot ulcers, post surgical wounds, first degree and partial thickness burns, grafted and donor sites).
Device Description
The ARMIS VeriCyn® Wound Wash is an aqueous solution for irrigation and debridement of wounds. The solution is a clear, colorless, no-odor aqueous solution that is used to remove debris, including microorganisms from wounds though the use of a lavage system. ARMIS VeriCyn® Wound Wash contains: Hydrogen Peroxide, Acetic Acid, Disodium EDTA and Purified water. VeriCyn® Wound Wash has been tested for compliance with ISO 10993.
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K Number
K202777Device Name
VeriFixx Small Bone Implant
Manufacturer
Armis Biopharma, Inc.
Date Cleared
2020-11-17
(56 days)
Product Code
HTY
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Armis Biopharma, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VeriFixx™ Small Bone Implant is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.
Device Description
The VeriFixx™ SBI is single use, gamma sterilized device that is surgically implanted into the intramedullary canal of the bones in the toe to create a fusion and provides stability and maintain the alignment of bone during the healing process. The device is a solid, non-threaded implant that has a superior surface protrusion known as the dorsal fin, which is intended to maintain alignment of the joint during the healing process.
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