AccessGUDID - DEVICE: Occlutech ASD Occluder (04260182521687)

GUDID

Device Identifier (DI) Information

Brand Name: Occlutech ASD Occluder
Version or Model: 37ASD33
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 37ASD33
Company Name: Occlutech GmbH

Primary DI Number: 04260182521687
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 312548545 *Terms of Use

Device Description: The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device, consisting of 2 nitinol wire mesh discs connected by a waist section and polyethylene terephthalate (PET) patches. The PET patches, sewn into the wire mesh, are intended to stop the blood flow through the ASD as well as optimize tissue growth. The design properties of the Occlutech ASD Occluder allow transcatheter implant of the device. The Occlutech ASD Occluder is packaged with its compatible Occlutech Pistol Pusher (OPP), Instructions for Use (IFU) and Patient Implant Card.

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
OZG	Transcatheter Septal Occluder (Atrial)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P200032	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
Storage Environment Temperature: between 5 and 30 Degrees Celsius
Special Storage Condition, Specify: Store Dry and Away from Sunlight

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 33 Millimeter

Device Record Status

Public Device Record Key: d23f1476-1561-4f0b-849f-9c7a88954c84
Public Version Date: March 13, 2024
Public Version Number: 1
DI Record Publish Date: March 05, 2024