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510(k) Data Aggregation
K Number
K211972Device Name
Omeza Collagen Matrix
Manufacturer
Date Cleared
2021-09-01
(69 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Omeza, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Omeza® Collagen Matrix is indicated for the management of wounds including:
- · Partial and full-thickness wounds
- · Pressure ulcers
- Venous ulcers
- · Diabetic ulcers
- · Chronic vascular ulcers
- · Tunneled/undermined wounds
- · Surgical wounds (donor sites/grafts, post-Moh's surgery, podiatric, wound dehiscence)
- · Trauma wounds (abrasions, lacerations, superficial thickness burns, skin tears)
- · Draining wounds
The device is intended for one-time use.
Device Description
Omeza® Collagen Matrix (OCM) is a wound care matrix comprised of hydrolyzed fish collagen infused with cod liver oil, which acts as an anhydrous skin protectant, and other plant-derived oils and waxes. When applied to a wound surface, the matrix is naturally incorporated into the wound over time. Omeza® Collagen Matrix is designed for intimate contact with both regular wound beds to providea conducive environment for the patient's natural wound healing process.
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