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510(k) Data Aggregation
K Number
K240753Device Name
Miro3D Fibers Wound Matrix
Manufacturer
Date Cleared
2024-04-19
(30 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Reprise Biomedical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Miro3D Fibers Wound Matrix is intended for the management of wounds including:
· Partial and full thickness wounds
- · Pressure ulcers
- · Venous ulcers
- · Chronic vascular ulcers
- · Diabetic ulcers
- · Tunneled, undermined wounds
- · Trauma wounds (abrasions, lacerations, partial thickness burns, and skin tears)
- · Draining wounds
- · Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence)
Device Description
The Miro3D Fibers Wound Matrix is a sterile, single use, non-crosslinked acellular wound dressing that is derived from porcine liver tissue. The liver is perfusion decellularized resulting in a collagen matrix that is dried and cut into fibers. The device is packaged dry and terminally sterilized in its packaging by e-beam irradiation. The Miro3D Fibers Wound Matrix may be used dry or rehydrated and is provided in four sizes by weight.
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K Number
K240277Device Name
MiroDry Wound Matrix
Manufacturer
Date Cleared
2024-03-01
(30 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Reprise Biomedical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MiroDry Wound Matrix is intended for the management of wounds including:
· Partial and full thickness wounds
- · Pressure ulcers
- · Venous ulcers
- · Chronic vascular ulcers
- · Diabetic ulcers
- · Tunneled, undermined wounds
- · Trauma wounds (abrasions, lacerations, partial thickness burns, and skin tears)
- · Draining wounds
- · Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence)
Device Description
The MiroDry Wound Matrix is a sterile, single use, non-crosslinked acellular wound dressing that is derived from porcine liver tissue. The liver is perfusion decellularized resulting in a collagen matrix that is dried and cut to defined sizes. The device is packaged dry, terminally sterilized in its packaging by e-beam irradiation and is rehydrated with sterile saline or Lactated Ringer's solution prior to use. The MiroDry Wound Matrix is provided in six sizes that may be cut to fit a wound size prior to application.
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K Number
K231614Device Name
MiroTract Wound Matrix
Manufacturer
Date Cleared
2023-12-13
(194 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Reprise Biomedical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MiroTract Wound Matrix is intended for the management of wounds including:
· Partial and full thickness wounds
- Pressure ulcers
- Venous ulcers
- · Chronic vascular ulcers
- · Diabetic ulcers
- · Tunneled, undermined wounds
- · Trauma wounds (abrasions, lacerations, partial-thickness burns, and skin tears)
- · Draining wounds
· Surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, wound dehiscence)
Device Description
The Reprise Biomedical MiroTract device consists of the MiroTract Wound Matrix and disposable delivery system. The MiroTract Wound Matrix is a sterile, single use, noncrosslinked acellular wound dressing that is derived from porcine liver tissue. The porcine liver is perfusion decellularized resulting in a collagen matrix that is dried, cut to size, and radially compressed onto the guidewire of the MiroTract delivery system. The delivery system includes a guidewire and tamp tube to manually push the MiroTract Wound Matrix off the guidewire into a wound. The MiroTract Wound Matrix porous scaffold provides a protective environment for wound healing. The MiroTract Wound Matrix is provided in two diameters (3 mm and 5 mm) and two lengths (5 cm and 9 cm). The MiroTract device is packaged dry in a plastic tray placed inside a foil pouch. The device is terminally sterilized in its packaging by e-beam irradiation. An optional Introducer Set accessory consisting of a tearaway sheath and dilator is provided in a separately packaged sterile pouch that is placed in a shelf box along with a MiroTract packaged device.
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K Number
K221520Device Name
Miro3D Wound Matrix
Manufacturer
Date Cleared
2022-08-18
(85 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Reprise Biomedical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Miro3D Wound Matrix is intended for the management of wounds including:
- Partial and full thickness wounds
- Pressure ulcers
- Venous ulcers
- Chronic vascular ulcers
- Diabetic ulcers
- Tunneled, undermined wounds
- Trauma wounds (abrasions, lacerations, second-degree burns, and skin tears)
- Draining wounds
- Surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, wound dehiscence)
Device Description
The Reprise Miro3D Wound Matrix is a sterile, single use, non-crosslinked acellular wound dressing that is derived from porcine liver tissue. The liver is perfusion decellularized resulting in a collagen matrix that is dried and cut to defined sizes. The Miro3D porous scaffold provides a protective environment for wound healing. The device is packaged dry, terminally sterilized in its packaging by e-beam irradiation and is rehydrated with sterile saline or lactated Ringer's solution prior to use. The Miro3D Wound Matrix is provided in four sizes that may be cut to fit a wound size prior to application.
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