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510(k) Data Aggregation
K Number
K232204Device Name
ReyaGel (RG03 - MTP gel 3mL)
Manufacturer
Date Cleared
2024-04-19
(269 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
FetTech
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
ReyaGel is intended for the management of wounds that include:
- · Partial and full thickness wounds
- · Pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers
- · Second degree burns
- · Surgical wounds donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence
- · Trauma wounds abrasions, lacerations, and skin tears
- · Tunneled/undermined wounds
- · Draining wounds
Device Description
ReyaGel Wound Gel is an extracellular matrix wound product composed of porcine spleen and lung extracellular matrix in a saline gel, for the management of wounds. It is an off-white gel supplied in a syringe for topical application. The product is provided sterile for single use.
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