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510(k) Data Aggregation
K Number
K060340Device Name
ORAMAGIC PLUS ORAL WOUND RINSE
Manufacturer
MPM MEDICAL, INC.
Date Cleared
2006-05-10
(89 days)
Product Code
OLR, MGO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
MPM MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the management of, and temporary relief of pain associated with, all types of mouth sores, ulcers of the oral mucosa including canker sores, aphthous ulcers, and injuries such as traumatic ulcers caused by braces and ill-fitting dentures.
Device Description
OraMagic™ Plus Oral Wound Rinse is a wound dressing containing 10% w/w benzocaine as a topical anesthetic intended for use in the local management of painful oral mucositis/stomatitis. The device is supplied non-sterile in plastic bottles containing 7.1 g or 25g of dry powder for reconstitution with water prior to use.
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K Number
K024180Device Name
ORAMAGICRX ORAL WOUND RINSE
Manufacturer
MPM MEDICAL, INC.
Date Cleared
2003-03-14
(86 days)
Product Code
OLR, MGQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
MPM MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the management of mucositis/stomatitis, all types of oral wounds (mouth sores and injuries), aphthous ulcers/canker sores, and traumatic ulcers caused by ill-fitting dentures or braces.
Device Description
OraMagicRx™ Oral Wound Rinse is a wound dressing designed for the management of oral mucositis/stomatitis. The device is supplied in plastic bottles containing 7.1 g, 25 g or 37.5 g of dry powder for reconstitution with water prior to use.
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K Number
K020540Device Name
REGENECARE WOUND GEL
Manufacturer
MPM MEDICAL, INC.
Date Cleared
2002-11-01
(255 days)
Product Code
MGQ, MGO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
MPM MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Local management of skin wounds, including pressure ulcers, venous stasis ulcers, first and second degree burns, and superficial wounds and scrapes.
Device Description
Regenecare™ Wound Gel is a viscous hydrogel wound dressing containing 2% w/w lidocaine as a topical anesthetic intended for use in the local management of painful skin wounds. The product is supplied sterile in plastic tubes.
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K Number
K992074Device Name
MPM REGENECARE WOUND GEL
Manufacturer
MPM MEDICAL, INC.
Date Cleared
1999-12-23
(188 days)
Product Code
MGQ, MGO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
MPM MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Local management of skin wounds, including pressure ulcers, venous stasis ulcers, first and second degree burns, and superficial wounds and scrapes.
Device Description
MPM Regenecare™ Wound Gel is a viscous hydrogel wound dressing intended for use in the local management of skin wounds. The product is supplied sterile in 3 oz. plastic tubes.
Biocompatibility of the device has been established by a primary dermal irritation test in rabbits, a sensitization test in guinea pigs, and an in vitro cytotoxicity test.
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K Number
K962160Device Name
MPM HYDROGEL DRESSING (NON-STERILE)
Manufacturer
MPM MEDICAL, INC.
Date Cleared
1996-06-26
(22 days)
Product Code
MGQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
MPM MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Local management of skin wounds, including pressure ulcers, Stage I-IV, stasis ulcers, first and second degree burns.
Device Description
The MPM Hydrogel Dressing is a clear, viscous, non-sterile, hydrogel intended for use in the local management of skin wounds. The product is supplied in 4 oz. tubes, 8 oz. spray bottles, and 0.5 oz. and 1.02. syringes and meets USP requirements for Antimicrobial Preservative Effectiveness.
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