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510(k) Data Aggregation
K Number
K080603Device Name
HYBRID NERVE LOCATION NEEDLE COATED AND UNCOATED
Manufacturer
Date Cleared
2008-08-05
(155 days)
Product Code
Regulation Number
868.5150Why did this record match?
Applicant Name (Manufacturer) :
TE ME NA SAS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Temena Nerve Location Needles are intended for use in regional anesthesia procedures, by anesthesiologists or other trained professionals, for the location of peripheral nerves with a nerve stimulator and/or with an ultrasound device.
Device Description
The Temena Hybrid and USC Nerve Location Needles include a stainless steel cannula and connections for anesthetic administration and with the Hybrid Needle a connection for nerve stimulation. The needle is available in a range of lengths and 21 or 22 AWG. The USC (uncoated version) may be used for echo nerve location and the Hybrid (coated version) for both stimulator and echo location.
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K Number
K060186Device Name
POLYPLEX STIMULATING CATHETER SYSTEM
Manufacturer
Date Cleared
2006-07-18
(175 days)
Product Code
Regulation Number
868.5140Why did this record match?
Applicant Name (Manufacturer) :
TE ME NA SAS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Te me na POLYPLEX Stimulating Catheter System is intended for placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.
Device Description
The Polyplex Stimulating Catheter System is an anesthesia conduction catheter that is electrically conductive. Using peripheral nerve stimulation, the clinician can locate specific nerves or nerve plexuses for continuous nerve block anesthesia or analgesia.
The Polyplex Stimulating Catheter System is available sterile in a kit with the necessary accessories required to perform the procedure and fix the catheter in place.
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