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510(k) Data Aggregation
K Number
K962917Device Name
MULTIDEX HYDROPHILIC WOUND DRESSING GEL
Manufacturer
Date Cleared
1996-12-16
(143 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
LANGE MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
MULTIDEX* Gel in a multi-use container is indicated for the management of stage II, III, IV pressure sores/ulcers, venous stasis ulcers, varicose ulcers, ischemic arterial ulcers, diabetic ulcers, neuropathic ulcers, poorly healing non-neoplastic wounds/ulcers and wounds/ulcers due to trauma. These are the identical indications as the predicate device.
Device Description
MULTIDEX* (polyglucose) Gel contains 66.9 percent Maltodextrin NF, one percent Ascorbic Acid, USP, 10 percent glycerin USP, 22 percent Purified Water USP, and 0.1 percent sorbic acid in a multi-use container. MULTIDEX Gel in a multi-use container contains the same ingredients as the predicate device with the addition of 0.1 percent sorbic acid as a preservative. It is packaged in a 90 gram low density polyethylene tube.
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K Number
K955399Device Name
MULTIDEX PLUS HYDROPHILIC WOUND DRESSING
Manufacturer
Date Cleared
1996-02-07
(75 days)
Product Code
Regulation Number
880.5090Why did this record match?
Applicant Name (Manufacturer) :
LANGE MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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