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Found 6 results
510(k) Data Aggregation
K Number
K130670Device Name
HYDROFERA BLUE PU BACTERIOSTATIC DRESSING
Manufacturer
HYDROFERA, LLC.
Date Cleared
2014-01-02
(296 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
HYDROFERA, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Hydrofera Blue PU Antibacterial Wound Dressings are intended as external dressings for use in local management of wounds such as pressure ulcers, donor sites, venous stasis ulcers, arterial ulcers, diabetic ulcers, abrasions, lacerations, superficial burns, post-surgical incisions and other external wound inflicted by trauma.
Device Description
Hydrofera Blue PU Antibacterial Dressing is a sterile absorptive foam dressing made of bacteriostatic polyurethane (PU) foam, Methylene blue (less than or equal to 0.00035g/g) and Crystal violet {less than or equal to 0.00035g/g]. The Hydrofera Blue PU dressing is a dry absorbent wound dressing. The foam contains two antimicrobials that provide broad- spectrum antimicrobial protection in the foam: 1. Methylene Blue- a known inorganic antimicrobial/ antifungal, widely accepted to kill gram negative bacteria 2. Gentian Violet (Crystal violet) a known inorganic antimicrobial/antifungal widely accepted to kill gram positive bacteria
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K Number
K023138Device Name
HYDROFERA BACTERIOSTATIC WOUND DRESSING
Manufacturer
HYDROFERA, LLC.
Date Cleared
2003-01-17
(119 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
HYDROFERA, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Hydrofera Bacteriostatic Wound Dressings are intended to use in the management of wounds such as minor cuts and scalds, abrasions, lacerations, and minor irritations of the skin.
Please contact a Healthcare professional before using this product if you are unsure whether you have any of these conditions or if you are unsure what type of wound you have.
Hydrofera BacteriostaticWound Dressings may also be used under the care of a Healthcare professional for use as external dressings in local management of wounds such as pressure ulcers, donor sites, venous stasis ulcers, arterial ulcers, díabetic ulcers, abrasions, lacerations, superficial burns, post surgical incisions, and other external wounds inflicted by trauma.
Device Description
Not Found
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K Number
K013462Device Name
HYDROFERA BACTERIOSTATIC WOUND DRESSING
Manufacturer
HYDROFERA, LLC.
Date Cleared
2002-01-11
(85 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
HYDROFERA, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Hydrofera Bacteriostatic Wound Dressings are intended as external dressings for use in local management of wounds such as pressure ulcers, donor sites, venous stasis ulcers, arterial ulcers, disbetic ulcers, abrasions, lacerations, and superficial hi post-surgical incisions, and other external wounds inflicted by trauma.
Device Description
Hydrofera Bacteriostatic Wound Dressings are blue in color and manufactured from a pure white synthetic material with absorbent sponge-like characteristics. The two pigments have been added to render the material bacteriostatic.
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K Number
K983276Device Name
HYDROFERA BACTERISTATIC NASAL DRESSING
Manufacturer
HYDROFERA, LLC.
Date Cleared
1999-09-14
(362 days)
Product Code
EMX
Regulation Number
874.4100Why did this record match?
Applicant Name (Manufacturer) :
HYDROFERA, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
POST OPERATIVE PACKING AFTER SEPTAL RHINOPLASTIC, OR TURBINATE SURGERY.
Device Description
BACTERISTATIC NASAL DRESSING
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K Number
K974313Device Name
HYDROFERA SURGICAL SPEAR
Manufacturer
HYDROFERA, LLC.
Date Cleared
1998-03-02
(105 days)
Product Code
HOZ
Regulation Number
886.4790Why did this record match?
Applicant Name (Manufacturer) :
HYDROFERA, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Hydrofera TM ophthalmic sponges are intended as external wicking device for use in local management of fluids during cataract surgery.
Device Description
Ophthalmic Sponge
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K Number
K974316Device Name
HYDROFERA FEMORAL WICK
Manufacturer
HYDROFERA, LLC.
Date Cleared
1998-02-13
(88 days)
Product Code
EFQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
HYDROFERA, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The absorbent dressing is indicated for use in hip arthroplasty.
Device Description
Not Found
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