AccessGUDID - DEVICE: GORE HELEX Septal Occluder (00733132606986)

GUDID

Device Identifier (DI) Information

Brand Name: GORE HELEX Septal Occluder
Version or Model: HX2020
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: W. L. Gore & Associates, Inc.

Primary DI Number: 00733132606986
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 967358115 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
45418	Cardiac defect occluder	An implantable disk-like device intended to be used for the minimally-invasive closure of cardiac defects and deployed using a dedicated delivery catheter/sheath. It is made of wire mesh [e.g., nickel-titanium alloy (Nitinol)], and possibly additional materials (e.g., polyester), and is typically self-expandable. The device is used to treat cardiac disorders that may include (but not limited to) atrial septal defect (ASD), ventricular septal defect (VSD), patent foramen ovale (PFO), or patent ductus arteriosus (PDA). Disposable devices dedicated to implantation may be included with the implant.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MLV	Transcatheter Septal Occluder

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P050006	037

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
Outer Diameter: 20 Millimeter
Length: 75 Centimeter

Device Record Status

Public Device Record Key: 4a42f41a-8786-415c-97d4-bd4ac41a2643
Public Version Date: April 08, 2022
Public Version Number: 6
DI Record Publish Date: February 13, 2017