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Found 9 results
510(k) Data Aggregation
K Number
K971612Device Name
OSMO/PCA PILLOW WOUND DRESSING
Manufacturer
PROCYTE CORP.
Date Cleared
1998-03-16
(318 days)
Product Code
KMF
Regulation Number
880.5090Why did this record match?
Applicant Name (Manufacturer) :
PROCYTE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A highly absorptive pillow dressing for the management of exudating wounds, infected and non-infected, including pressure ulcers, diabetic ulcers, venous stasis ulcers, arterial ulcers, 1st and 2nd degree burns, donor sites, postoperative incisions, other bleeding surface wounds, dermal lesions, trauma injuries or incisions.
Device Description
Osmo/PCA Pillow Wound Dressing utilizes the hydrophilic polymer granules contained in a mesh pillow to absorb up to 20 times their weight in wound exudate. Since the granules are contained in the mesh pillow, they are easily removed, thereby significantly reducing the possibility of retaining granules within the wound and allowing the Osmo/PCA Pillow Wound Dressing to be utilized in wounds with deep cavities or tunnels. Osmo/PCA Pillow Wound Dressing contains highly absorptive polymer granules able to absorb up to 20 times their weigh in wound exudate. The granules are encased in an inert low density polyethylene mesh fabric which allow the wound exudate to pass through and be absorbed by the polymer granules but which contains the granules, thus allowing for the dressing's easy removal from cavity or tunnel wounds.
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K Number
K972150Device Name
OSMOCYTE ISLAND WOUND DRESSING
Manufacturer
PROCYTE CORP.
Date Cleared
1997-12-10
(184 days)
Product Code
KMF
Regulation Number
880.5090Why did this record match?
Applicant Name (Manufacturer) :
PROCYTE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A self adhesive highly absorptive island dressing for the management of exudating wounds, infected and non-infected, including pressure ulcers, diabetic ulcers, venous stasis ulcers, arterial ulcers, 1st and 2nd degree burns, donor sites, postoperative incisions, other bleeding surface wounds, dermal lesions, trauma injuries or incisions, cuts, abrasions and general first aid.
Device Description
OsmoCyte® Island Wound Dressing utilizes a powdered polymer absorbent pad contained in a non-woven mesh pillow attached to a sheet of foam polyurethane and coated with a medical grade acrylic emulsion adhesive.
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K Number
K972329Device Name
OSMOCYTE RA WOUND DRESSING
Manufacturer
PROCYTE CORP.
Date Cleared
1997-12-10
(170 days)
Product Code
KMF
Regulation Number
880.5090Why did this record match?
Applicant Name (Manufacturer) :
PROCYTE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Exudating wounds, infected or non-infected including pressure ulcers, diabetic ulcers, venous stasis ulcers, arterial ulcers, 1st and 2nd degree burns, donor sites, postoperative incisions, other bleeding surface wounds, dermal lesions, trauma injuries or incisions, cuts, abrasions and general first aid.
Device Description
OsmoCyte® RA Wound Dressing utilizes a powdered polymer absorbent pad contained in a non-woven mesh pillow attached to a sheet of foam polyurethane and coated with a medical grade acrylic emulsion adhesive.
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K Number
K970153Device Name
LAMIN-2 HYDRATING GEL
Manufacturer
PROCYTE CORP.
Date Cleared
1997-06-05
(140 days)
Product Code
MGQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
PROCYTE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
lamin®-2 Hydrating Gel is intended to be used for the dressing and management of pressure ulcers (stage I-IV), diabetic ulcers, stasis ulcers, 1st and 2nd degree burns, arterial ulcers, pressure sores, cuts, abrasions, irritations of the skin, and skin conditions associated with peristomal care. The dressing is intended to cover a wound or burn on a patient's skin, provide a moist wound environment and protect against abrasion, friction, desiccation, and external contamination.
Device Description
lamin®-2 Hydrating Gel acts to provide a moist wound environment and protect the wound. lamin®-2 Hydrating Gel was designed to provide a soothing, moist environment for each application to various types of wounds. lamin®-2 Hydrating Gel Wound Dressing is a low bioburden, preserved preparation of water, glycerin, carbopol (carbomer), prezatide copper acetate and parabens to form a hydrogel dressing.
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K Number
K965143Device Name
OSMOCYTE WOUND MANAGER SHEET DRESSING
Manufacturer
PROCYTE CORP.
Date Cleared
1997-05-22
(150 days)
Product Code
MGQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
PROCYTE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OsmoCyte™ Wound Manager Sheet Dressing is indicated for the management of partial and full thickness wounds, both chronic and acute, with low to moderate exudate, including the following: Pressure ulcers, diabetic ulcers, venous stasis ulcers, arterial ulcers, 18 and 200 degree burns, donor sites, postoperative incisions, minor chemical and thermal burns, superficial lacerations, cuts and abrasions, severe sunburn, dermal lesions (e.g. poison ivy), trauma injuries or incisions.
Device Description
A sterile, hydropolymer dressing which protects the wound and provides a moist wound environment for low to moderate exudating wounds.
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K Number
K965005Device Name
IAMIN IMPREGNATED GAUZE DRESSING
Manufacturer
PROCYTE CORP.
Date Cleared
1997-02-24
(70 days)
Product Code
MGQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
PROCYTE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
lamin Impregnated Gauze Dressing is intended to be used for the dressing and management of pressure ulcers (stage I-IV), diabetic ulcers, stasis ulcers, 1st and 2nd degree burns, arterial ulcers, pressure sores, cuts, abrasions, irritations of the skin, and skin conditions associated with peristomal care. The dressing is intended to cover a wound or burn on a patient's skin, provide a moist wound environment and protect against abrasion, friction, desiccation, and contamination.
Device Description
lamin® Impregnated Gauze Dressing acts to provide a moist wound environment and protect the wound. lamin® Impregnated Gauze Dressing was designed to provide a soothing, moist environment for each application to various types of wounds as an impregnated gauze dressing. lamin® Impregnated Gauze Dressing is sterile impregnated cotton-blend non-woven gauze.
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K Number
K964468Device Name
IAMIN WET DRESSING (COPPER-SALINE)
Manufacturer
PROCYTE CORP.
Date Cleared
1997-02-03
(89 days)
Product Code
MGQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
PROCYTE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A hydrogel for the dressing and management of both graft recipient and donor sites, postoperative incisions, pressure ulcers, diabetic ulcers, stasis ulcers, 1st and 2nd degree burns, arterial ulcers, pressure sores, and skin conditions associated with peristomal care. The dressing is intended to cover a wound or burn on a patient's skin, provide a moist wound environment, absorb wound exudate, and protect against abrasion, friction, desiccation, and contamination.
Device Description
lamin® Wet Dressing (Copper-Saline) is sterile saturated cotton-blend non-woven gauze.
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K Number
K962623Device Name
OSMOCYTE ULTRA/PE PILLOW WOUND DRESSING
Manufacturer
PROCYTE CORP.
Date Cleared
1996-11-26
(144 days)
Product Code
KMF
Regulation Number
880.5090Why did this record match?
Applicant Name (Manufacturer) :
PROCYTE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
An absorptive pillow dressing for the management of exudating wounds, infected and noninfected, including pressure ulcers, diabetic ulcers, venous stasis ulcers, 1st and 2nd degree burns, donor sites, postoperative incisions, other bleeding surface wounds, dermal lesions, trauma injuries or incisions.
Device Description
OsmoCyte™ Ultra/PE Pillow Wound Dressing utilizes the hydrophilic polymer granules contained in a mesh pillow to absorb many times their weight in wound exudate. Since the granules are contained in the mesh pillow, they are easily removed, thereby significantly reducing the possibility of retaining granules within the wound and allowing the OsmoCyte™ Ultra/PE Pillow Wound Dressing to be utilized in wounds with deep cavities or tunnels. OsmoCyte™ Ultra/PE Pillow Wound Dressing contains a highly absorptive polymer able to absorb many times its weight in wound exudate. The granules are encased in an inert low density polyethylene mesh fabric which allow the wound exudate to pass through and be absorbed by the polymer granules but which contains the granules, thus allowing for the dressing's easy removal from cavity or tunnel wounds.
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K Number
K953853Device Name
IAMIN GEL WOUND DRESSING
Manufacturer
PROCYTE CORP.
Date Cleared
1996-02-05
(173 days)
Product Code
MGQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
PROCYTE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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