AccessGUDID - DEVICE: FlexCath Cross Transseptal Solution (00850027837994)

GUDID

Device Identifier (DI) Information

Brand Name: FlexCath Cross Transseptal Solution
Version or Model: 900311
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ACUTUS MEDICAL, INC.

Primary DI Number: 00850027837994
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 844418199 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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):	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?
65073	Cardiac transseptal access electrosurgical dilator/needle	A luminal, one-piece, electrosurgical device designed to be used with a transseptal vascular guide-catheter (not included) to penetrate the interatrial septum for left-heart access during a transseptal catheterization procedure. It is typically a long, thin tube that is curved and round-nosed at the distal end for positioning against the atrial septum, and incorporates an extendable, sharp needle in its lumen able to apply radio-frequency (RF) alternating current in a monopolar configuration. It may have radiopaque markers for positioning and enable acquisition of an intracardiac electrocardiogram (ECG); a guidewire and connection cables may also be included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DYB	Introducer, Catheter
DRE	Dilator, Vessel, For Percutaneous Catheterization

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K233691	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: a7f93dba-0bcb-4b08-b02d-24be544f0c81
Public Version Date: December 28, 2023
Public Version Number: 1
DI Record Publish Date: December 20, 2023