Freedom - ProFlor Inguinal Hernia Kit FIHR 40mmEK

GUDID 00013964672152

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 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 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 ID00013964672152
NIH Device Record Key047e8e94-3cbb-49b7-891c-758edb7762ef
Commercial Distribution Discontinuation2019-12-05
Commercial Distribution StatusNot in Commercial Distribution
Brand NameFreedom - ProFlor Inguinal Hernia Kit
Version Model NumberFIHR 40mmEK
Catalog NumberFIHR 40mmEK
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

Phone9319192955
Emailwayne.lyle@insightra.com
Phone9319192955
Emailwayne.lyle@insightra.com
Phone9319192955
Emailwayne.lyle@insightra.com
Phone9319192955
Emailwayne.lyle@insightra.com
Phone9319192955
Emailwayne.lyle@insightra.com
Phone9319192955
Emailwayne.lyle@insightra.com
Phone9319192955
Emailwayne.lyle@insightra.com
Phone9319192955
Emailwayne.lyle@insightra.com
Phone9319192955
Emailwayne.lyle@insightra.com
Phone9319192955
Emailwayne.lyle@insightra.com
Phone9319192955
Emailwayne.lyle@insightra.com
Phone9319192955
Emailwayne.lyle@insightra.com
Phone9319192955
Emailwayne.lyle@insightra.com
Phone9319192955
Emailwayne.lyle@insightra.com
Phone9319192955
Emailwayne.lyle@insightra.com
Phone9319192955
Emailwayne.lyle@insightra.com
Phone9319192955
Emailwayne.lyle@insightra.com
Phone9319192955
Emailwayne.lyle@insightra.com
Phone9319192955
Emailwayne.lyle@insightra.com
Phone9319192955
Emailwayne.lyle@insightra.com
Phone9319192955
Emailwayne.lyle@insightra.com
Phone9319192955
Emailwayne.lyle@insightra.com
Phone9319192955
Emailwayne.lyle@insightra.com
Phone9319192955
Emailwayne.lyle@insightra.com
Phone9319192955
Emailwayne.lyle@insightra.com
Phone9319192955
Emailwayne.lyle@insightra.com
Phone9319192955
Emailwayne.lyle@insightra.com
Phone9319192955
Emailwayne.lyle@insightra.com
Phone9319192955
Emailwayne.lyle@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
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
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter
Outer Diameter40 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100013964672152 [Primary]

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 Date2019-12-06
Device Publish Date2015-07-22

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

00837654352885The Insightra Medical Freedom Inguinal Hernia Implant (ProFlor™) is a sterile, polypropylene i
00837654352878The Insightra Medical Freedom Inguinal Hernia Implant (ProFlor™) is a sterile, polypropylene i
00013964672367The Insightra Medical Freedom Inguinal Hernia Implant (ProFlor™) is a sterile, polypropylene i
00013964672152The Insightra Medical Freedom Inguinal Hernia Implant (ProFlor™) is a sterile polypropylene im
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