Freedom - ProFlor Inguinal Hernia Implant FIHR 40mm

GUDID 00013964672381

The Insightra Medical Freedom Inguinal Hernia Implant (ProFlor™) is a sterile, polypropylene implant device designed for use in the open repair of inguinal hernias. A delivery device, sold separately, is used to deploy the implant into the prepared hernia defect site.

INSIGHTRA MEDICAL, INC.

Abdominal hernia surgical mesh, composite-polymer

• Primary Device ID: 00013964672381
• NIH Device Record Key: 4d2f730f-3b89-470a-aaf8-65f04de0eab4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Freedom - ProFlor Inguinal Hernia Implant
• Version Model Number: FIHR 40mm
• Catalog Number: FIHR 40mm
• Company DUNS: 097664937
• Company Name: INSIGHTRA MEDICAL, INC.
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 949-215-1835
• Email: raqa@insightra.com
• Phone: 949-215-1835
• Email: raqa@insightra.com
• Phone: 949-215-1835
• Email: raqa@insightra.com
• Phone: 949-215-1835
• Email: raqa@insightra.com
• Phone: 949-215-1835
• Email: raqa@insightra.com
• Phone: 949-215-1835
• Email: raqa@insightra.com
• Phone: 949-215-1835
• Email: raqa@insightra.com
• Phone: 949-215-1835
• Email: raqa@insightra.com
• Phone: 949-215-1835
• Email: raqa@insightra.com
• Phone: 949-215-1835
• Email: raqa@insightra.com
• Phone: 949-215-1835
• Email: raqa@insightra.com
• Phone: 949-215-1835
• Email: raqa@insightra.com
• Phone: 949-215-1835
• Email: raqa@insightra.com
• Phone: 949-215-1835
• Email: raqa@insightra.com
• Phone: 949-215-1835
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com

Device Dimensions

• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00013964672381 [Package]; Contains: 00850012832072; Package: [6 Units]; In Commercial Distribution
GS1	00850012832072 [Primary]
GS1	00850012832089 [Package]; Contains: 00850012832072; Package: Shipper Box Implant [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113552

FDA Product Code

• FTL: Mesh, Surgical, Polymeric

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-11
• Device Publish Date: 2015-07-22

On-Brand Devices [Freedom - ProFlor Inguinal Hernia Implant]

• 00013964672176: The Insightra Medical Freedom Inguinal Hernia Implant (ProFlor™) is a sterile, polypropylene i
• 00013964672381: The Insightra Medical Freedom Inguinal Hernia Implant (ProFlor™) is a sterile, polypropylene i
• 00850012832041: The Insightra Medical Freedom Inguinal Hernia Implant (ProFlor™) is a sterile, polypropylene i
• 00013964672374: The Insightra Medical Freedom Inguinal Hernia Implant (ProFlor™) is a sterile, polypropylene i