DEVICE: CorPath 200 Robotic Drive Drape (00081628002213)
Device Identifier (DI) Information
CorPath 200 Robotic Drive Drape
160-00828
In Commercial Distribution
160-00828
CORINDUS, INC.
160-00828
In Commercial Distribution
160-00828
CORINDUS, INC.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Cardiac mapping system workstation | A mains electricity (AC-powered) device designed as a control unit to percutaneously navigate (orientate and steer) a cardiac mapping system catheter, or its associated guidewire, in the desired direction to the designated target site (e.g., coronary vasculature). It uses dedicated software and may employ various technologies (often magnetic fields); it is typically used in the electrophysiology (EP) laboratory. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DXX | System, Catheter Control, Steerable |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
f2a65da1-abd1-459d-ab4d-ae5e73ba3c92
March 29, 2018
2
September 24, 2016
March 29, 2018
2
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00081628002212
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
508-653-3335
cutomer.service@corindus.com
cutomer.service@corindus.com