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510(k) Data Aggregation
K Number
K063309Device Name
TRU-CABLE
Manufacturer
TRUPHATEK INTERNATIONAL, LTD.
Date Cleared
2007-01-12
(71 days)
Product Code
FFS
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
TRUPHATEK INTERNATIONAL, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tru-Cable™ endoscopic fiber optic cable is designed to transmit light for illumination purposes from a remote source to an endoscope or similar surgical instrument. It can be adapted to be compatible with a variety of illuminators.
Device Description
The Truphatek Tru-Cable™ endoscopic fiber optic cables are:
- . Lengths of 10 feet (3.5m)
- Diameters 3.5mm and 5.0mm .
- The fiber optic cable is hermetically sealed in a closed system so that it can be . sterilized or high level disinfected using most common methods.
- The cables are sold non-sterile. .
The fiber optic cables are designed for use with all the most popular light source illuminators and surgical instruments that are equipped with standard endoscopic adapters. They are designed for user high level disinfection and / or sterilization by autoclave or high level disinfection may be done via Steris® or Liquid Chemicals, i.e. Cidex OPA®. The cable is rated for 100 uses when processed via autoclave.
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K Number
K062523Device Name
TRU-MR LARYNGOSCOPE SET
Manufacturer
TRUPHATEK INTERNATIONAL, LTD.
Date Cleared
2006-11-17
(81 days)
Product Code
CCW
Regulation Number
868.5540Why did this record match?
Applicant Name (Manufacturer) :
TRUPHATEK INTERNATIONAL, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tru-MR TM laryngoscope set is used to facilitate and aid in tracheal intubation in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.
Device Description
The Truphatek Tru-MRTM MR conditional laryngoscope handle, battery, and blades are standard blades and handles that have been specially treated to be useable in a magnetic resonance (MR) environment. Testing has been performed according to ASTM F2052-02 in a 3.0 Tesla environment. There are many handle and blade configurations offered.
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