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Artisan® - HANSEN MEDICAL INC - In Depth Guide

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HANSEN MEDICAL INC - Artisan® : Product InformationBack to Top


 Artisan®
 In Commercial Distribution
 HANSEN MEDICAL, INC.
 10815671020007
 GS1
 NA
 1
 Artisan Family Catheter Sterile Drape

Artisan® - Device Characteristics


MRI safety Status Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437) No
Device labeled as "Not made with natural rubber latex" No
For Single-Use True
Prescription Use (Rx) True
Over the Counter (OTC) No
Kit No
Combination Product No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P) No

Artisan® - GMDN


GMDN Preferred Term Name GMDN Definition
Instrument/equipment drape, single-use, sterile A sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various surgical and/or non-surgical instruments/equipment [e.g., surgical tray, operating room (OR) equipment table, endoscope and endoscopic instruments, surgical cameras and lasers], to provide a barrier against cross-contamination in various clinical settings. This is a single-use device. See also: Instrument/equipment drape dispenser

Artisan® - Sterilization


 True
 No

HANSEN MEDICAL INC - Artisan® : Product Code InformationBack to Top


FDA Product Code

Product Code Product Code Name
DXX System, Catheter Control, Steerable