AccessGUDID - DEVICE: EasyFinder Fixed Curve Diagnostic Catheter (06952450952450)

GUDID

Device Identifier (DI) Information

Brand Name: EasyFinder Fixed Curve Diagnostic Catheter
Version or Model: EPD6FB005
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Shanghai Microport Ep Medtech Co., Ltd.

Primary DI Number: 06952450952450
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 542965535 *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":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
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?
46355	Cardiac mapping catheter, percutaneous, single-use	A sterile, steerable, flexible tube containing multiple electrodes that is introduced percutaneously into the heart chambers in order to transmit electrical impulses for electrophysiological diagnostic examinations, e.g., intracardiac sensing, endocardial recording, stimulation, temporary pacing for evaluation of cardiac arrhythmias, cardioversion (CV) of electrical arrhythmias or electrophysiology (EP) mapping of cardiac structures. It is typically made of plastic with embedded electrodes often of platinum (Pt), iridium, or a composite. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K210313	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: 4746ceff-8fc2-4558-a26a-f6df1f6e6815
Public Version Date: February 29, 2024
Public Version Number: 1
DI Record Publish Date: February 21, 2024