Bard® DeBakey® Woven Polyester Fabric, 10.2 cm x 10.2 cm
Bard® DeBakey® Woven Polyester Fabric - 007955
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
- Width: 10.2 Centimeter
- Length: 10.2 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 IdentifiersDevice Id: 10801741041256
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00801741041259
Package Quantity: 5
Package Discontinue Date: 11/29/2022 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: CA
Device Id: 00801741041259
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