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Found 7 results
510(k) Data Aggregation
K Number
K022670Device Name
CARRAKLENZ AND ULTRAKLENZ
Manufacturer
CARRINGTON LABORATORIES, INC.
Date Cleared
2002-10-17
(66 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
CARRINGTON LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Carrington Wound Cleansers are surfactant wound cleansers intended for the removal of foreign material such as dirt and debris from dermal wounds. CarraKlenz is a wound cleanser that is indicated for high, medium, and low exudating wounds. UltraKlenz is a gentle wound cleanser which is used on intact skin.
Device Description
The Carrington CarraKlenz Wound Cleansers are wound cleaning solutions that are intended for the cleansing and irrigation of dermal wounds. The Carrington Wound Cleansers work by mechanical action on the dermal wounds. The pressure of the liquid flowing onto the wound aids in the removal of the debris from the wound. The Carrington Wound Cleansers are offered in various bottle sizes.
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K Number
K012126Device Name
THE SALICEPT ORAL PATCH
Manufacturer
CARRINGTON LABORATORIES, INC.
Date Cleared
2001-10-03
(89 days)
Product Code
OLR, MGQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
CARRINGTON LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Recommended for use in tooth extraction sites and management of alveolar osteitis (dry socket). The SaliCept Oral Patch is also intended for the management of all types of oral wounds, injuries and ulcers of the oral mucosa. The Salicept Oral Patch relieves pain by adhering to and protecting affected tissues from further irritation.
Device Description
The SaliCept Oral Patch is a freeze-dried gel that contains Acemannan Hydrogel," a product obtained from the clear inner gel of Aloe vera L. Other ingredients include hydroxyethyl cellulose, polyvinylpyrrolidone, benzethonium chloride, simethicone. It is pliable, white to off-white, with a texture similar to that of finely woven cotton. The SaliCept Oral Patch is packaged in blister cards of six pledgets per card, two blister cards per carton, for a total of 12 pledgets per carton. Each pledget is approximately 1 cm in diameter and 0.5 cm thick.
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K Number
K983182Device Name
ALOE THERAPY ORAL RINSE
Manufacturer
CARRINGTON LABORATORIES, INC.
Date Cleared
1998-12-10
(90 days)
Product Code
OLR, MGQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
CARRINGTON LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Carrington Laboratories Caraloe Oral Rinse provides fast pain relief and is recommended for the conning of a lives of oral wounds, mouth sore injuries and ulcers of the oral mucosa, including canker son s and traumatic ulcers such as those caused by braces and ill-fitting dentures. Safe if swallowed
Device Description
Caraloe Oral Rinse
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K Number
K964852Device Name
RADIACARE ORAL WOUND RINSE
Manufacturer
CARRINGTON LABORATORIES, INC.
Date Cleared
1997-03-03
(90 days)
Product Code
OLR
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
CARRINGTON LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
wound dressing designed for the management of oral mucositis/stomatitis.
Device Description
RadiaCare™ Oral Wound Rinse is a wound dressing designed for the management of oral mucositis/stomatitis. The oral wound rinse is equivalent to the predicate device, Carrasyn® Oral Wound Dressing. Determination if substantial equivalence for this device was based on descriptive information about the design, materials and intended use of the device. The ingredients used in RadiaCare™ Oral Wound Rinse are the same as used in Carrasyn Oral Wound Dressing or are food-grade materials.
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K Number
K962218Device Name
CARRASYN HYDROGEL WOUND DRESSING,CARRAGAUZE PADS,CARRAGAUZE STRIPS,CARRASORB M FDG
Manufacturer
CARRINGTON LABORATORIES, INC.
Date Cleared
1996-09-12
(94 days)
Product Code
MGQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
CARRINGTON LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Carrasyn wound dressings are either smooth, nonoily clear hydrogels or freeze-dried preparations of the same. They are supplied in either a liquid or dry state and are designed to be used in conjunction with an appropriate cover dressing and are intended for the management of wounds.
Device Description
Carrasyn wound dressings are either smooth, nonoily clear hydrogels or freeze-dried preparations of the same. They are supplied in either a liquid or dry state and are designed to be used in conjunction with an appropriate cover dressing and are intended for the management of wounds.
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K Number
K961758Device Name
CARASYN HYDROGEL WOUND PRODUCTS
Manufacturer
CARRINGTON LABORATORIES, INC.
Date Cleared
1996-07-11
(69 days)
Product Code
MGQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
CARRINGTON LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Carrasyn™ wound dressings are either smooth, nonoily clear hydrogels or freeze-dried preparations of the same. They are supplied in either a liquid or dry state and are intended for the management of wounds.
Device Description
Carrasyn™ wound dressings are either smooth, nonoily clear hydrogels or freeze-dried preparations of the same. They are supplied in either a liquid or dry state and are intended for the management of wounds.
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K Number
K960428Device Name
CARRASYN HYDROGEL WOUND DRESSING/FDG PADS/CARAGAUZE STRIPS/PADS (MODIFICATION)
Manufacturer
CARRINGTON LABORATORIES, INC.
Date Cleared
1996-03-21
(69 days)
Product Code
MGQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
CARRINGTON LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
intended for the management of wounds.
Device Description
Carrasyn™ wound dressings are either smooth, nonoily clear hydrogels or freeze-dried preparations of the same. They are supplied in either a liquid or dry state and are designed to be used in conjunction with an appropriate cover dressing
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