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510(k) Data Aggregation
K Number
K092257Device Name
JALOSKIN
Manufacturer
FIDIA ADVANCED BIOPOLYMERS SRL
Date Cleared
2010-01-26
(182 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
FIDIA ADVANCED BIOPOLYMERS SRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
JALOSKIN is indicated for the management of superficial moderately exuding wounds including pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, skin tears) and first and second degree burns.
Device Description
JALOSKIN is a semi-permeable, transparent film dressing, composed of HYAFF® 11, a benzyl ester of hyaluronic acid. The hyaluronic acid is derived from bacterial fermentation.
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K Number
K073251Device Name
HYALOMATRIX PA
Manufacturer
FIDIA ADVANCED BIOPOLYMERS SRL
Date Cleared
2007-12-14
(25 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
FIDIA ADVANCED BIOPOLYMERS SRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HYALOMATRIX® is indicated for the management of wounds including: partial and full-thickness wounds; second-degree burns; pressure ulcers; venous ulcers; diabetic ulcers; chronic vascular ulcers; tunneled/undetermined wounds; surgical wounds (donor sites/grafts, post-Moh's surgery , post-laser surgery, podiatric, wound dehiscence); trauma wounds (abrasions, lacerations, skin tears); and draining wounds. The device is intended for one-time use.
Device Description
HYALOMATRIX is a bilayered, sterile, flexible, and conformable wound dressing that acts as an advanced wound care device. It is comprised of a nonwoven pad entirely composed of HYAFF 11, a benzyl ester of hyaluronic acid, and a semipermeable silicone membrane, which controls water vapor loss, provides a flexible covering for the wound surface, and adds increased tear strength to the device. The HYAFF 11 wound contact layer biodegradable matrix acts as a scaffold for cellular invasion and capillary growth.
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K Number
K001508Device Name
LASERSKIN DRESSING
Manufacturer
FIDIA ADVANCED BIOPOLYMERS SRL
Date Cleared
2001-07-25
(436 days)
Product Code
MGP
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
FIDIA ADVANCED BIOPOLYMERS SRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K003855Device Name
HYALOMATRIX CO
Manufacturer
FIDIA ADVANCED BIOPOLYMERS SRL
Date Cleared
2001-07-03
(202 days)
Product Code
KHJ
Regulation Number
874.3620Why did this record match?
Applicant Name (Manufacturer) :
FIDIA ADVANCED BIOPOLYMERS SRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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