Search Results
Found 2 results
510(k) Data Aggregation
K Number
K112864Device Name
SOFTSEAL-C
Manufacturer
Date Cleared
2012-08-02
(307 days)
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
CHITOGEN, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
SoftSeal-C is indicated for use in the management of minor topical bleeding wounds such as minor abrasions and minor skin lacerations.
Device Description
SoftSeal-C pad is a sterile topical pad, packed in a foil pouch, and sterilized with gamma irradiation to a 10-6 SAL. The SoftSeal-C pad is a non-woven pad composed of chitosan fibers attached to a thin polypropylene backing material. The SoftSeal-C is formed as a 1" by 1" square pad 0.4" thick. The soft, fleece-like pad consists of fine (5 to 20 micrometer) chitosan fibers spun from high molecular weight chitosan. The chitosan fleece is attached to a thin polypropylene backing, which provides dimensional support for fabricating and handling the soft fibers.
Ask a Question
Ask a specific question about this device
K Number
K090100Device Name
SOFTSEAL-STF
Manufacturer
Date Cleared
2009-03-11
(55 days)
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
CHITOGEN, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
SoftSeal-STF is indicated for use in the management of bleeding wounds such as skin lacerations, vascular access sites, or percutaneous catheter or tube sites. SoftSeal promotes the rapid control of bleeding for patients on hemodialysis and patients on anticoagulation therapy.
Device Description
SoftSeal-STF is a sterile topical pad, packaged in a foil pouch, and sterilized with gamma irradiation to a SAL of 10-6.
Ask a Question
Ask a specific question about this device
Page 1 of 1