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510(k) Data Aggregation
K Number
K081404Device Name
SPINAL INTEGRATION SPINAL-EZE INTRAOPERATIVE EPIDURAL CATHETER KIT
Manufacturer
Date Cleared
2008-10-21
(155 days)
Product Code
Regulation Number
868.5120Why did this record match?
Applicant Name (Manufacturer) :
SPINAL INTEGRATION LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Spinal-EZE™ Intraoperative Epidural Catheter Kit is intended to provide intraoperative single dose delivery of local anesthetic and/or narcotics to the epidural space adjacent to the cauda equina when the epidural injection is accessible as a result of surgery to the spinal column through the epidural space. The only clinical setting for administration for the Spinal-EZE™ Intraoperative Epidural Catheter is intraoperative. The device is provided sterile and is intended for single-use only.
Device Description
The Spinal-EZE™ Intraoperative Epidural Catheter Kit consists of a catheter assembly with a .027" ID x .060" OD that is 60 cm long with an atraumatic bullet shaped closed tip. The catheter has depth marks at 100mm increments and 6 pairs of punched holes .56mm to .61mm in diameter positioned 90° apart at 3mm increments beginning 19.99mm from the catheter tip. The catheter is manufactured from 60 durometer Barium sulfate loaded (5%) silicone elastomer. Also included in the kit is a 10cc Syringe marked "epidural", a blunt tip 65cm long Teflon coated guide wire to assist in maneuvering the catheter during insertion, a Luer lock and cap assembly to facilitate attachment of the catheter to the syringe.
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