- Physicians Office Resource

Bard® Edwards Outflow Tract Knitted PTFE Fabric, 15.2 cm x 15.2 cm
Bard® Edwards Outflow Tract Knitted PTFE Fabric - 007835

Device Description

An implantable material designed to reinforce suture lines and/or increase the strength of weak or injured cardiac and/or peripheral vascular tissues during cardiovascular repair/reconstruction procedures (e.g., annulus or septal defect repair, endarterectomy, profundaplasty). It is a non-bioabsorbable perforated patch made of synthetic polymer material [e.g., polypropylene, polytetrafluoroethylene (PTFE) or Teflon, felt], without biological materials, that is typically implanted with sutures. It is typically implanted during cardiovascular procedures but may also be used in other open and/or laparoscopic soft-tissue surgical procedures (e.g., hernia repair).

Environmental Conditions

No Data Available

Device Sizes

Length: 15.2 Centimeter

Width: 15.2 Centimeter

Length: 15.2 Centimeter
Width: 15.2 Centimeter

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: DXZ

Device Name: Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 870.3470

Third Party Flag: N

Medical Specialty: CV

Device Identifiers

Device Id: 10801741041096

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00801741041099

Package Quantity: 5

Package Discontinue Date: 9/20/2023 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: CA

Device Id: 00801741041099

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

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