Occlutech ASD Occluder Procedure Pack 37ASD10P

GUDID 07340175601972

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 (04260182521540) is packaged with its compatible Occlutech Pistol Pusher (OPP) (8683463400161), Instructions for Use (IFU) and Patient Implant Card.

Occlutech International AB

Cardiac defect occluder

• Primary Device ID: 07340175601972
• NIH Device Record Key: 224d6548-0ff6-4f3f-8239-31c1c0150c60
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Occlutech ASD Occluder Procedure Pack
• Version Model Number: 37ASD10P
• Catalog Number: 37ASD10P
• Company DUNS: 775466951
• Company Name: Occlutech International AB
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• 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: 10.5 Millimeter
• Outer Diameter: 10.5 Millimeter
• Outer Diameter: 10.5 Millimeter
• Outer Diameter: 10.5 Millimeter
• Outer Diameter: 10.5 Millimeter
• Outer Diameter: 10.5 Millimeter
• Outer Diameter: 10.5 Millimeter
• Outer Diameter: 10.5 Millimeter
• Outer Diameter: 10.5 Millimeter
• Outer Diameter: 10.5 Millimeter
• Outer Diameter: 10.5 Millimeter
• Outer Diameter: 10.5 Millimeter
• Outer Diameter: 10.5 Millimeter
• Outer Diameter: 10.5 Millimeter
• Outer Diameter: 10.5 Millimeter
• Outer Diameter: 10.5 Millimeter
• Outer Diameter: 10.5 Millimeter
• Outer Diameter: 10.5 Millimeter

Operating and Storage Conditions

• 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
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07340175601972 [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 ASD Occluder Procedure Pack]

• 07340175602085: The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device
• 07340175602078: The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device
• 07340175602061: The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device
• 07340175602054: The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device
• 07340175602047: The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device
• 07340175602030: The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device
• 07340175602023: The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device
• 07340175602016: The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device
• 07340175602009: The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device
• 07340175601996: The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device
• 07340175601989: The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device
• 07340175601972: The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device
• 07340175601965: The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device
• 07340175601958: The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device
• 07340175601941: The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device