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Found 8 results
510(k) Data Aggregation
K Number
K083721Device Name
MODIFICATION TO ZENIEVA
Manufacturer
RIVER'S EDGE PHARMACEUTICALS, LLC
Date Cleared
2009-01-08
(24 days)
Product Code
NAE
Regulation Number
878.4022Why did this record match?
Product Code :
NAE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Zenieva is used to manage and relieve the burning and itching experienced with various types of dermatoses, including radiation dermatitis, atopic dermatitis, and allergic contact dermatitis. Zenieva helps relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
Device Description
Zenieva is a non-sterile, semi-viscous emulsion intended for topical application. It is presented for prescription (requires a physician diagnosis of disease state) use. The product is formulated as an oil-in-water emulsion containing a cross-linked polyacrylic acid polymer, natural gum, and cellulose as thickening agents. The oil composition of Zenieva is composed of glyceride, squalane, lecithin, and fatty acids.
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K Number
K082865Device Name
MODIFICATION TO ZENIEVA
Manufacturer
GORBEC PHARMACEUTICAL SERVICES, INC.
Date Cleared
2008-10-23
(24 days)
Product Code
NAE
Regulation Number
878.4022Why did this record match?
Product Code :
NAE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Zenieva is used to manage and relieve the burning and itching experienced with various types of dermatoses, including radiation dermatitis, atopic dermatitis, and allergic contact dermatitis. Zenieva helps relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
Device Description
Zenieva is a non-sterile, semi-viscous emulsion intended for topical application. It is presented for prescription (requires a physician diagnosis of disease state) use. The product is formulated as an oil-in-water emulsion containing a crosslinked polyacrylic acid polymer, natural gum, and cellulose as thickening agents. The oil composition of Zenieva is composed of glyceride, squalane, lecithin, and fatty acids.
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K Number
K073246Device Name
ZENIEVA
Manufacturer
GORBEC PHARMACEUTICAL SERVICES, INC.
Date Cleared
2008-07-23
(247 days)
Product Code
NAE
Regulation Number
878.4022Why did this record match?
Product Code :
NAE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Zenieva is used to manage and relieve the burning and itching experienced with various types of dermatoses, including radiation dermatitis, atopic dermatitis, and allergic contact dermatitis. Zenieva helps relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
Device Description
Zenieva is a non-sterile, semi-viscous emulsion intended for topical application. It is presented for prescription (requires a physician diagnosis of disease state) use. The product is formulated as an oil-in-water emulsion containing a crosslinked polyacrylic acid polymer, natural gum, and cellulose as thickening agents. The oil composition of Zenieva is composed of glyceride, squalane, lecithin, and fatty acids.
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K Number
K992094Device Name
GILTECH PLUS HYDROGEL SKIN DRESSING
Manufacturer
GILTECH PLUS, INC.
Date Cleared
1999-09-17
(88 days)
Product Code
NAE, MGQ
Regulation Number
878.4022Why did this record match?
Product Code :
NAE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Giltech Plus Hydrogel Wound Dressing is intended to be used in the management of.
1. Minor burns
2. Decubitus ulcers
3. Superficial lacerations, cuts and abrasions
4. Postoperative incisions
5. Sunburn
Device Description
This hydrogel retains cold temperature. Its' high specific heat, due to high water content, allows it to have a cooling effect.
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K Number
K991061Device Name
DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING
Manufacturer
DERMAPHYLYX, INC.
Date Cleared
1999-06-28
(90 days)
Product Code
NAE, MGQ
Regulation Number
878.4022Why did this record match?
Product Code :
NAE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dermaphylyx Calcium Alginate Wound Dressings are intended for use in the management of a variety of partial and full-thickness wounds. The dressings are additionally intended to help control minor bleeding.
The following Indications are for Prescription Use or under the direction of a health care professional:
- Venous ulcers
- Diabctic ulcers
- Pressure ulcers
- Arterial ulcers
- Superficial burns
- Abrasions and lacerations
- Donor sites
- Postoperative wounds
The following Indications are for Over-the-Counter Use:
- Abrasions
- Minor Burns
- Minor Cuts
- Minor Lacerations
Device Description
Dermaphylyx Calcium Alginate Wound Dressings consist of calcium alginate fibers fabricated into felt and rope configurations. Dermaphylyx Calcium Alginate Wound Dressings are engineered to absorb substantial quantities of wound cxudate. During the absorption of exudate the dressing forms a gel/liber mat. The formation of the gel/fiber mat may help facilitate removal from the wound.
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K Number
K972646Device Name
AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES
Manufacturer
LUDLOW TECHNICAL PRODUCTS
Date Cleared
1997-08-21
(37 days)
Product Code
NAE, MGQ
Regulation Number
878.4022Why did this record match?
Product Code :
NAE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This hydrogel dressing is a sterile wound dressing for the management of partial thickness wounds, first and second degree burns, donor sites and superficial injuries. Ad-Heal™ Bydrogel Dressing is indicated for: First and Second Degree Burns Partial Thickness Wounds Donor Sites Pressure Ulcers Abrasions Note: Ad-Healm is not indicated for full thickness or infected wounds or for third degree burns. This is a disposable, short term (less than 72 hours between changes) device for single patient use
Device Description
This hydrogel dressing is a sterile wound dressing for the management of partial thickness wounds, first and second degree burns, donor sites and superficial injuries. This is a disposable, short term (less than 72 hours between changes) device for single patient use
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K Number
K971597Device Name
COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903)
Manufacturer
COLOPLAST CORP.
Date Cleared
1997-07-29
(89 days)
Product Code
NAE, MGQ
Regulation Number
878.4022Why did this record match?
Product Code :
NAE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use in the management of leg ulcers and pressure sores. The gel provides a moist wound healing environment which encourages natural autolytic debridement.
Device Description
Comfeel® Purilon Gel is an absorbent hydrogel wound dressing composed of calcium alginate, sodium carboxymethylcellulose and purified water. The product is supplied sterile in 15 g and 25 g plastic bellow tubes.
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K Number
K962352Device Name
HYDROGEL SKIN DRESSING
Manufacturer
NORTH AMERICAN STERILIZATION & PACKAGING CO.
Date Cleared
1996-08-02
(45 days)
Product Code
NAE
Regulation Number
878.4022Why did this record match?
Product Code :
NAE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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