FDA-Device2014-04-23Class II
CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows: 82-8800 In Line Valve Only 82-8801 In Line Valve with Catheter and Accessories 82-8802 In Line Valve with Unitized Catheter and Accessories 82-8803 In line Valve with Unitized BACTISEAL Catheter and Accessories 82-8804 In Line Valve only with SIPHONGUARD Device 82-8805 In Line Valve with SIPHONGUARD Device, Catheter and Accessories 82-8806 In Line Valve with SIPHONGUARD, Unitized Catheter and Accessories
Codman & Shurtleff, Inc.
Hazard
Ensuring all customers have the tools to assist in verifying the setting of the valve on x-ray images and the location and orientation of implanted CODMAN CERTAS Programmable Valves.
Sold states
Nationwide Distribution.
Affected count
9,445 units
Manufactured in
325 Paramount Drive, N/A, Raynham, MA, United States
Products
CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows: 82-8800 In Line Valve Only 82-8801 In Line Valve with Catheter and Accessories 82-8802 In Line Valve with Unitized Catheter and Accessories 82-8803 In line Valve with Unitized BACTISEAL Catheter and Accessories 82-8804 In Line Valve only with SIPHONGUARD Device 82-8805 In Line Valve with SIPHONGUARD Device, Catheter and Accessories 82-8806 In Line Valve with SIPHONGUARD, Unitized Catheter and Accessories 82-8807 In Line Valve with SIPHONGUARD Device, Unitized BACTISEAL Catheter and Accessories 82-8850 Certas Therapeutic Management System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1468-2014Don't want to check this manually?
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