AccessGUDID - DEVICE: CorPath GRX Drape, Robotic Drive and Arm (00816280023093)

GUDID

Device Identifier (DI) Information

Brand Name: CorPath GRX Drape, Robotic Drive and Arm
Version or Model: 309
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 309
Company Name: Corindus, Inc.

Primary DI Number: 00816280023093
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 781746586 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
31742	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.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K160121	000
K173288	000
K202275	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 171b2581-5315-437f-900d-0528c7ce14c2
Public Version Date: October 19, 2022
Public Version Number: 7
DI Record Publish Date: January 20, 2017