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 Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer
Primary Device ID00013964672381
NIH Device Record Key4d2f730f-3b89-470a-aaf8-65f04de0eab4
Commercial Distribution StatusIn Commercial Distribution
Brand NameFreedom - ProFlor Inguinal Hernia Implant
Version Model NumberFIHR 40mm
Catalog NumberFIHR 40mm
Company DUNS097664937
Company NameINSIGHTRA MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone949-215-1835
Emailraqa@insightra.com
Phone949-215-1835
Emailraqa@insightra.com
Phone949-215-1835
Emailraqa@insightra.com
Phone949-215-1835
Emailraqa@insightra.com
Phone949-215-1835
Emailraqa@insightra.com
Phone949-215-1835
Emailraqa@insightra.com
Phone949-215-1835
Emailraqa@insightra.com
Phone949-215-1835
Emailraqa@insightra.com
Phone949-215-1835
Emailraqa@insightra.com
Phone949-215-1835
Emailraqa@insightra.com
Phone949-215-1835
Emailraqa@insightra.com
Phone949-215-1835
Emailraqa@insightra.com
Phone949-215-1835
Emailraqa@insightra.com
Phone949-215-1835
Emailraqa@insightra.com
Phone949-215-1835
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com

Device Dimensions

Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
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Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
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Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
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Outer Diameter40 Millimeter
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Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
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Outer Diameter40 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100013964672381 [Package]
Contains: 00850012832072
Package: [6 Units]
In Commercial Distribution
GS100850012832072 [Primary]
GS100850012832089 [Package]
Contains: 00850012832072
Package: Shipper Box Implant [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FTLMesh, Surgical, Polymeric

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-11
Device Publish Date2015-07-22

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

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