Devices

Sierra Scientific Motility Visualization System (MVS)

Model / Serial
F1112702UA, F1113101UA, F1113103UA, F1113104UA, F1113401UA, F1114201UA, F1114617UA, F1114618UA, F1114619UA, F1114620UA, F1114621UA, F1114623UA, F1114624UA, F1114625UA, F1114626UA, F1114627UA, F1114628UA, F1114629UA, F1115402UA, F1116306UA, F1117207UA, F1119201UA, F1119401UA, F1121304UA, F1123201UA, F1123405UA, F1123703UA, F1124202UA, F1124301UA, F1125105UA, F1125201UA, F1127303UA, F1128101UA, F1129701UA, F1130202UA, F1130304UA, F1128301UA, F1127103UA, F1127205UA,
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA (nationwide) and the countries of: Austria, Belgium, Canada, Chile, China, Columbia, Ecuador, France, Germany, Israel, Mexico, Poland, Portugal, Sweden, and Switzerland.
Product Description
AR ManoShield, MSS-3599, 10 pack. || FGS: MSS-3599, || Individual package label: LBL-110275-03, || Box label: LBL-110282-03, || Package Inserts: DOC-3682, || User Manual: DOC-1332-12. || Product Usage: The MVS disposable sheath (a.k.a. ManoShield) for the high-resolution MVS catheter is designed to provide a biocompatible barrier between the catheter and patient.
Manufacturer
Sierra Scientific Instruments Inc
1 Event
- Recall of Sierra Scientific Motility Visualization System (MVS)

Manufacturer

Sierra Scientific Instruments Inc

Manufacturer Address
Sierra Scientific Instruments Inc, 5757 W Century Blvd Ste 660, Los Angeles CA 90045-6456
Source
USFDA

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