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510(k) Data Aggregation
K Number
K212579Device Name
FortiShield (Biosynthetic Wound Matrix)
Manufacturer
Date Cleared
2023-05-02
(624 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Organogenesis Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
FortiShield is intended for use as a temporary wound covering, and to provide a moist wound healing environment on cleanly debrided wounds after hemostasis has been established.
FortiShield is indicated for: partial thickness wounds, pressure sores, venous ulcers, diabetic ulcers, chronic vascular ulcers, surgical wounds (donor sites/grafts, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, partial thickness burns, and skin tears) and draining wounds.
Device Description
FortiShield is a sterile, translucent biosynthetic wound matrix made from a knitted tri-filament nylon fabric that is mechanically bonded to a semi-permeable silicone membrane. Denatured porcine dermal collagen is bonded to the nylon/silicone bi-layer membrane to provide a dressing that is designed to adhere to the application site, provide a barrier to the external environment, and allow for excess exudate drainage.
FortiShield is not made with natural rubber latex. FortiShield is non-pyrogenic.
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K Number
K220317Device Name
PuraPly Micronized Wound Matrix (PuraPly MZ)
Manufacturer
Date Cleared
2022-07-01
(148 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Organogenesis Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
PuraPly® Micronized Wound Matrix (PuraPly® MZ) is intended for the management of wounds that include:
- · Partial and full-thickness wounds
- Pressure ulcers
- Venous ulcers
- · Diabetic ulcers
- Chronic vascular ulcers
- · Tunneled/undermined wounds
- Surgical wounds (e.g., donor sites/grafts, post-Mohs' surgery, Podiatric wound, and wound dehiscence).
- · Trauma wounds (e.g., abrasions, lacerations, and skin tears)
- Partial thickness burns
- Draining wounds
The device is intended for single patient use only.
Device Description
PuraPly® Micronized Wound Matrix (PuraPly® MZ) consists of micronized porcine collagen intended for the management of wounds. PuraPly® Micronized Wound Matrix is supplied as a dry powder of particle size of ≤ 1000μm. The device is sterile and packaged in a vial sealed in a single pouch.
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