Search Results
Found 12 results
510(k) Data Aggregation
K Number
K050086Device Name
BRENNEN MEDICAL SILVER GLUCAN WOUND DRESSING
Manufacturer
BRENNEN MEDICAL, INC.
Date Cleared
2006-02-17
(400 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
BRENNEN MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Silver Glucan Wound Dressing is an effective barrier to bacterial and candida penetration. The dressing may be use for partial and full thickness wounds including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, donor sites, and surgical wounds. Silver Glucan dressings may be used over partial thickness wounds, debrided wounds, and as a temporary covering for full thickness and grafted wounds.
Device Description
Silver Glucan dressing consists of a nylon mesh coated with silver and oat glucan. The glucan facilitates the placement of the mesh and the silver protects the wound site from bacterial and yeast contamination.
The sterile, single use dressing will be sold in a variety of sizes ranging from 4" x 4" to 16" x 16" and rolls of 4" x 48".
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K Number
K030460Device Name
MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX
Manufacturer
BRENNEN MEDICAL, INC.
Date Cleared
2003-03-07
(23 days)
Product Code
PAG
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
BRENNEN MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use in the treatment of hernias where the connective tissue has ruptured or as a sling material to support the repositioning and support of the bladder neck for female urinary incontinence resulting from urethral hypermobility or sphincter deficiency.
Device Description
(Trade name) is a sterile, processed and treated porcine skin, which is intended for use in the reconstruction of soft tissue deficiencies.
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K Number
K021835Device Name
BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX
Manufacturer
BRENNEN MEDICAL, INC.
Date Cleared
2002-10-17
(135 days)
Product Code
FTL
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
BRENNEN MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Glucamesh™/Glucatex™ Surgical Mesh is intended for the use as a prosthesis in general surgery for surgical treatment of abdominal wall reinforcement, hernia repairs, eventrations, rectal and genitourinary prolapse. The meshes are biocompatible and not biodegradable. The device is intended to be implanted by a qualified surgeon.
Device Description
Glucatex mesh is constructed of polypropylene or polyester which is identical in composition to that used in Prolene Soft Mesh, Mersitence or Biomesh. The mesh affords excellent strength, durability and surgical adaptability, with sufficient porosity for necessary tissue ingrowth.
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K Number
K002077Device Name
GLUCANPRO CREAM
Manufacturer
BRENNEN MEDICAL, INC.
Date Cleared
2000-10-02
(84 days)
Product Code
MGQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
BRENNEN MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K002078Device Name
BETA GLUCAN GEL (MACROPRO GEL)
Manufacturer
BRENNEN MEDICAL, INC.
Date Cleared
2000-10-02
(84 days)
Product Code
MGQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
BRENNEN MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000518Device Name
MACROPRO GEL
Manufacturer
BRENNEN MEDICAL, INC.
Date Cleared
2000-05-01
(75 days)
Product Code
MGQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
BRENNEN MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000519Device Name
GLUCANPRO
Manufacturer
BRENNEN MEDICAL, INC.
Date Cleared
2000-05-01
(75 days)
Product Code
MGQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
BRENNEN MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K982825Device Name
BRENNEN MEDICAL BETA GLUCAN GEL
Manufacturer
BRENNEN MEDICAL, INC.
Date Cleared
1998-11-06
(87 days)
Product Code
MGQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
BRENNEN MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Brennen Beta Glucan Gel may be used to aid in the management of superficial and partial thickness burns; pressure ulcers (stages I-IV); venous, diabetic, and arterial ulcers; donor graft sites; superficial through full thickness wounds such as surgical wounds, minor abrasions and lacerations; and irritations of the skin.
Brennen Glucan Gel provides a moist environment which supports in the autolytic debridement of wounds with scattered areas of necrosis and slough.
Device Description
Brennen Medical Beta Glucan Gel
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K Number
K982403Device Name
BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX
Manufacturer
BRENNEN MEDICAL, INC.
Date Cleared
1998-09-22
(74 days)
Product Code
PAG
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
BRENNEN MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Brennen Biosynthetic Surgical Mesh is indicated in the treatment of hernias where the connective tissue has ruptured or as a sling material to support the repositioning and support of the bladder neck for female winary incontinence resulting from urethral hypermobility or sphincter deficiency.
Device Description
Brennen Biosynthetic Surgical Mesh Matrix
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K Number
K980962Device Name
BRENNEN MEDICAL BETA GLUCAN CREAM, MACROPRO
Manufacturer
BRENNEN MEDICAL, INC.
Date Cleared
1998-07-29
(135 days)
Product Code
MGQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
BRENNEN MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MacroPro Cream may be used to aid in the management of superficial and partial thickness burns; pressure ulcers (stages I-IV); venous, diabetic, and arterial ulcers; donor graph sites; superficial through full thickness wounds such as surgical wounds, minor abrasions and lacerations; and irritations of the skin.
MacroPro Cream provides a moist environment which supports in the autolytic debridement of wounds with scattered areas of necrosis and slough.
For external use only. Do not use on patients with known allergies to plants such as gum oat.
Device Description
Brennen Medical Beta Glucan Cream, "MacroPro"
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