Occlutech Pistol Pusher 38PP125

GUDID 08683463400161

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.

OCCLUTECH TIBBI URUNLER SANAYI VE TICARET LIMITED SIRKETI

Cardiac defect occluder

• Primary Device ID: 08683463400161
• NIH Device Record Key: d8a1b9f2-3907-47f5-8bd5-d4c9dcb581a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Occlutech Pistol Pusher
• Version Model Number: 38PP125
• Catalog Number: 38PP125
• Company DUNS: 502656748
• Company Name: OCCLUTECH TIBBI URUNLER SANAYI VE TICARET LIMITED SIRKETI
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 877-836-2228
• Email: xx@xx.xx
• Phone: 877-836-2228
• Email: xx@xx.xx
• Phone: 877-836-2228
• Email: xx@xx.xx
• Phone: 877-836-2228
• Email: xx@xx.xx
• Phone: 877-836-2228
• Email: xx@xx.xx
• Phone: 877-836-2228
• Email: xx@xx.xx
• Phone: 877-836-2228
• Email: xx@xx.xx
• Phone: 877-836-2228
• Email: xx@xx.xx
• Phone: 877-836-2228
• Email: xx@xx.xx
• Phone: 877-836-2228
• Email: xx@xx.xx
• Phone: 877-836-2228
• Email: xx@xx.xx
• Phone: 877-836-2228
• Email: xx@xx.xx
• Phone: 877-836-2228
• Email: xx@xx.xx
• Phone: 877-836-2228
• Email: xx@xx.xx
• Phone: 877-836-2228
• Email: xx@xx.xx
• Phone: 877-836-2228
• Email: xx@xx.xx
• Phone: 877-836-2228
• Email: xx@xx.xx
• Phone: 877-836-2228
• Email: xx@xx.xx

Device Dimensions

• Outer Diameter: 2.13 Millimeter
• Length: 120 Centimeter
• Outer Diameter: 2.13 Millimeter
• Length: 120 Centimeter
• Outer Diameter: 2.13 Millimeter
• Length: 120 Centimeter
• Outer Diameter: 2.13 Millimeter
• Length: 120 Centimeter
• Outer Diameter: 2.13 Millimeter
• Length: 120 Centimeter
• Outer Diameter: 2.13 Millimeter
• Length: 120 Centimeter
• Outer Diameter: 2.13 Millimeter
• Length: 120 Centimeter
• Outer Diameter: 2.13 Millimeter
• Length: 120 Centimeter
• Outer Diameter: 2.13 Millimeter
• Length: 120 Centimeter
• Outer Diameter: 2.13 Millimeter
• Length: 120 Centimeter
• Outer Diameter: 2.13 Millimeter
• Length: 120 Centimeter
• Outer Diameter: 2.13 Millimeter
• Length: 120 Centimeter
• Outer Diameter: 2.13 Millimeter
• Length: 120 Centimeter
• Outer Diameter: 2.13 Millimeter
• Length: 120 Centimeter
• Outer Diameter: 2.13 Millimeter
• Length: 120 Centimeter
• Outer Diameter: 2.13 Millimeter
• Length: 120 Centimeter
• Outer Diameter: 2.13 Millimeter
• Length: 120 Centimeter
• Outer Diameter: 2.13 Millimeter
• Length: 120 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Dry and Away from Sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Dry and Away from Sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Dry and Away from Sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Dry and Away from Sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Dry and Away from Sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Dry and Away from Sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Dry and Away from Sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Dry and Away from Sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Dry and Away from Sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Dry and Away from Sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Dry and Away from Sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Dry and Away from Sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Dry and Away from Sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Dry and Away from Sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Dry and Away from Sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Dry and Away from Sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Dry and Away from Sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Dry and Away from Sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	08683463400161 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P200032

FDA Product Code

• OZG: Transcatheter Septal Occluder (Atrial)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-13
• Device Publish Date: 2024-03-05

On-Brand Devices [Occlutech Pistol Pusher]

• 08683463400222: The Occlutech Pistol Pusher is a medical device compatible with the Occlutech Atrial Septal Defe
• 08683463400208: The Occlutech Pistol Pusher is a medical device compatible with the Occlutech Atrial Septal Defe
• 08683463400185: The Occlutech Pistol Pusher is a medical device compatible with the Occlutech Atrial Septal Defe
• 08683463400161: The Occlutech Pistol Pusher is a medical device compatible with the Occlutech Atrial Septal Defe