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510(k) Data Aggregation
K Number
K964256Device Name
CYGNUS INSTRUMENT PROTECTORS
Manufacturer
Date Cleared
1997-05-06
(193 days)
Product Code
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
MADISON POLYMERIC ENGINEERING
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The primary purpose of the device is to protect surgical instruments during sterilization, storage and transportation to the surgical suite. This product is intended to be used by hospital staff during the preparation of the sterile instrument kits.
Device Description
The "Cygnus Instrument Protectors" liners and pouches are constructed with reticulated polyurethane ester foam. The material's open cell structure allows for the free flow of air, moisture and heat and is virtually free of particulate matter. The variety of sizes and shapes allows for greater flexibility in padding the instruments. Tray liners are available in precut sheets and rolls. uthe pouches are available in three sizes of single pouches and two sizes of multi pouch rolls. The pouches are formed by heat sealing the edges and seams. Each product is available in individual boxes as well as bulk case packaging. The products are shipped and marked as "non sterile" and "disposable". Each box is marked with a control lot number and universal bar code.
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K Number
K965086Device Name
CYGNUS ELECTROSURGICAL TIP CLEANER
Manufacturer
Date Cleared
1997-02-14
(57 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
MADISON POLYMERIC ENGINEERING
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The primary purpose of the device is to provide a convenient and effective surface for cleaning the tips of electrosurgical cutting and coagulation instruments. The design of the pad is such that the device may be used during surgery and in conjunction with the electrosurgical instrument.
Device Description
The body of the device is constructed of a polyurethane ester foam. A grit sheet is laminated to the top surface of the foam, and a pressure sensitive adhesive and release liner laminated to the base of the pad. An X-Ray detectable rod is placed between the pressure sensitive adhesive and the foam. The device is available in three sizes. Each pad is individually wrapped and sterilized for use. Sterilization will be by Gamma Ray or ETO and will be conducted and certified by a contract sterilization firm.
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