AccessGUDID - DEVICE: Occlutech Pistol Pusher (08683463400208)

GUDID

Device Identifier (DI) Information

Brand Name: Occlutech Pistol Pusher
Version or Model: 38PP185
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 38PP185
Company Name: OCCLUTECH TIBBI URUNLER SANAYI VE TICARET LIMITED SIRKETI

Primary DI Number: 08683463400208
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 502656748 *Terms of Use

Device Description: The Occlutech Pistol Pusher is a medical device compatible with the Occlutech Atrial Septal Defect Occluder (Occlutech ASD Occluder) and applications with special cardiac catheters in the human heart.The Occlutech Pistol Pusher is composed of proximal body and distal parts. The distal part consists of titanium alloy jaws and a stainless-steel container while the body part is polymer laminated stainless steel coil. The proximal parts of the Occlutech Pistol Pusher largely contains plastic components. The jaws and container mechanism grab and secure the ball connector of the compatible Occlutech ASD Occluder and allow retraction of the Occlutech ASD Occluder into the ODS III and advancement to the implant area. The proximal part has a trigger for releasing the compatible Occlutech ASD Occluder and a locking mechanism for locking the system to prevent unintentional release. The Occlutech Pistol Pusher is available in different sizes for compatibility with the Occlutech ASD Occluders.

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):	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: 2.93 Millimeter
Length: 120 Centimeter

Device Record Status

Public Device Record Key: 27fd2e16-b12e-4541-bd99-58b6866d0d86
Public Version Date: March 13, 2024
Public Version Number: 1
DI Record Publish Date: March 05, 2024