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Found 8 results
510(k) Data Aggregation
K Number
K063190Device Name
SILVERSEAL WOUND PACKING STRIPS WITH X-STATIC
Manufacturer
NOBLE FIBER TECHNOLOGIES, INC.
Date Cleared
2007-08-21
(305 days)
Product Code
QSY, FRO, LYA
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
NOBLE FIBER TECHNOLOGIES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Silverseal® Wound Packing Strips with X-Static® are intended for the control of local wound bleeding and nasal hemorrhage, and to encourage draining by wicking fluids from a body cavity, infected area, or abscess, and to help remove necrotic tissue from ulcers or other infected wounds when used as a wet-to-dry packing.
Device Description
SILVERSEAL® Wound Packing Strip with X-Static® is a flexible, non-adherent, protective dressing consisting of nylon fibers with a metallic silver surface. It is made of flexible, sterile, non-adherent fabric consisting of a knitted continuous nylon fiber substrate with a metallic silver surface containing approximately 1.5% silver oxide.
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K Number
K050726Device Name
SILVERSEAL SILVERAID WITH X-STATIC
Manufacturer
NOBLE FIBER TECHNOLOGIES, INC.
Date Cleared
2005-12-05
(262 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
NOBLE FIBER TECHNOLOGIES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For over-the-counter use, SILVERSEAL® Adhesive Strips with X-Static® may be used for: First aid to help in minor abrasions, minor cuts, lacerations, scrapes, minor scalds and burns. Under the supervision of a health care professional, SILVERSEAL® Adhesive Strips may be used for the management of: SILVERSEAL® Adhesive Strips with X-Static® are sterile, non-adherent dressings intended for local management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure and diabetic).
Device Description
SILVERSEAL® Adhesive Strips with X-Station are designed to intimately contact the wound as a primary dressing and permit the passage of fluids. The silver provides effective protection of the dressing abainst microbial contamination. The nylon fabric permits the passage of exygen and fluids to and from the wound. The surface of the nylon fibers in SILVERSEAL® Adhesive Strips with X-Static; consists or a thin layer of approximately 22. metallic silver containing approximately 1.5 silver oxide that provides effective protection of the dressing against microbial contamination. SILVERSEAL: Adhesive Strips are made of flexible, sterile, non-adherent fabric consisting of a knitted continuous nylon fiber substrate with 22% metallic silver surface containing approximately 1.58 silver oxide.
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K Number
K051256Device Name
SILVERSEAL ORTHOTIC COMPONENT WITH X-STATIC
Manufacturer
NOBLE FIBER TECHNOLOGIES, INC.
Date Cleared
2005-07-21
(66 days)
Product Code
ISH
Regulation Number
890.3420Why did this record match?
Applicant Name (Manufacturer) :
NOBLE FIBER TECHNOLOGIES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SILVERSEAL® Orthotic Components with X-Static® are used as components on various orthotic devices intended for medical purposes that can be worn as a cervical collar or brace. The component comprises a knitted stockinette which is made of 90% cotton or polyester, and 10% X-Static®, which is 1.5% silver oxide. The component provides the skin with an antimicrobial barrier.
Device Description
SILVERSEAL® Orthotic Components with X-Static® are made of flexible, non-adherent fabric consisting of a knitted or made or in fabric which is 90% cotton or polyester, and 10% of a continuous nylon fiber substrate with a metallic silver surface containing approximately 1.5% silver oxide.
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K Number
K050649Device Name
SILVERSEAL CONTACTING WOUND DRESSING WITH X-STATIC
Manufacturer
NOBLE FIBER TECHNOLOGIES, INC.
Date Cleared
2005-06-13
(91 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
NOBLE FIBER TECHNOLOGIES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For over-the-counter use, Silverseal® Wound Contact Dressing with X-Static® may be used for first aid management of minor abrasions, cuts, scrapes, scalds and burns.
Under the supervision of a health care professional, Silverseal® Contact Wound Dressing may be used for the management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure and diabetic).
Device Description
SILVERSEAL® Burn Contact Wound Dressings with X-Static® are designed to intimately contact the wound as a primary dressing and permit the passage of fluids. The silver provides effective protection of the dressing against microbial contamination.
The nylon fabric permits the passage of oxygen and fluids to and from the wound. The surface of the nylon fibers in SILVERSEAL® Contact Wound Dressings with X-Static® consists of a thin layer of metallic silver containing approximately 1.5% silver oxide that provides effective protection of the dressing against microbial contamination.
SILVERSEAL® Contact Wound Dressings are made of flexible, sterile, non-adherent fabric consisting of a knitted continuous nylon fiber substrate with a metallic silver surface containing approximately 1.5% silver oxide.
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K Number
K043526Device Name
SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC
Manufacturer
NOBLE FIBER TECHNOLOGIES, INC.
Date Cleared
2005-03-10
(79 days)
Product Code
LGF
Regulation Number
888.5940Why did this record match?
Applicant Name (Manufacturer) :
NOBLE FIBER TECHNOLOGIES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K033900Device Name
X-STATIC SILVERSEAL HYDROCOLLOID FILM AND ISLAND DRESSING
Manufacturer
NOBLE FIBER TECHNOLOGIES
Date Cleared
2005-01-14
(394 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
NOBLE FIBER TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
X-Static® SILVERSEAL™ Hydrocolloid Film and Island Dressings indicated for: partial and full thickness dermal ulcers, leg ulcers (vascular, venous, pressure and diabetic), superficial wounds, abrasions, first and second degree burns, and donor sites.
Device Description
X-Static® SILVERSEAL™ Hydrocolloid Film and Island Dressings are designed to intimately contact the wound as a primary dressing and permit the passage of fluids. Laboratory antibacterial testing has demonstrated that the silver provides effective protection of the dressing against microbial contamination. The nylon fabric permits the passage of oxygen and fluids to and from the wound. The surface of the nylon fibers in X-Static® SILVERSEAL™ Hydrocolloid Film and Island Dressing consists of a thin layer of metallic silver containing approximately 1.5% of 99% elemental silver that provides effective protection of the dressing against microbial contamination. Physical Description: 4 % x 4 % OD with a 2.5" x 2.0" square silver-colloid pad. The pad will consist of a colloid-film laminate, laminated to X-Static silver-plated nylon, number 90203.
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K Number
K033587Device Name
SILVERSEAL
Manufacturer
NOBLE FIBER TECHNOLOGIES
Date Cleared
2004-08-05
(266 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
NOBLE FIBER TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
X-Static® SILVERSEAL™ Contact Wound Dressings are sterile, non-adherent dressings intended for local management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure, and diabetic).
Device Description
X-Static® SILVERSEAL™ Contact Wound Dressings are designed to intimately contact the wound as a primary dressing and permit the passage of fluids. The silver provides effective protection of the dressing against microbial contamination. The nylon fabric permits the passage of oxygen and fluids to and from the wound. The surface of the nylon fibers in X-Static® SILVERSEAL™ Contact Wound Dressing consists of a thin layer of metallic silver containing approximately 1% silver oxide that provides effective protection of the dressing against microbial contamination. X-Static® SILVERSEAL™ Contact Wound Dressings are made of flexible, sterile, non-adherent fabric consisting of 1 or 4 layers of a knitted continuous nylon fiber substrate with a metallic silver surface containing approximately 1% silver oxide.
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K Number
K040019Device Name
SILVERSEAL
Manufacturer
NOBLE FIBER TECHNOLOGIES
Date Cleared
2004-07-23
(199 days)
Product Code
MGQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
NOBLE FIBER TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The X-Static® Silverseal™ Hydrogel Wound Dressing is intended for the management of wounds and to provide an antimicrobial barrier. The dressing is indicated for use on partial and full thickness dermal ulcers, leg ulcers, superficial wounds, abrasions, first and second degree burns, donor sites and over debrided and grafted partial thickness wounds.
Device Description
X-Static® SILVERSEAL™ Hydrogel Wound Dressings are designed to intimately contact the wound as a primary dressing and permit the passage of fluids. The silver provides effective protection of the dressing against microbial contamination. The nylon fabric permits the passage of oxygen and fluids to and from the wound. The surface of the nylon fibers in X-Static® SILVERSEAL™ Hydrogel Wound Dressing consists of a thin layer of metallic silver containing approximately 1.5% silver oxide that provides effective protection of the dressing against microbial contamination. X-Static® SILVERSEAL™ ilydrogel Wound Dressings are made of flexible, sterile, non-adherent fabric consisting of 1 layer of a knitted continuous nylon fiber substrate with metallic silver surface containing approximately 1% silver oxide.
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