Freedom - Ventral Hernia Repair System FVHR20X30

GUDID 00837654352984

The Freedom™ Ventral Hernia Repair System consists of a synthetic and permanent polypropylene Octomesh™ implant and a disposable strap passer. The implant has a central body with 8 radiating straps. The straps pass through the abdominal wall, leaving them lying in tissue tunnels created by the passer. The straps hold the body of the mesh in place.

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 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 ID00837654352984
NIH Device Record Key00907cd2-08cf-4e27-b725-24a44739dbfa
Commercial Distribution StatusIn Commercial Distribution
Brand NameFreedom - Ventral Hernia Repair System
Version Model NumberFVHR20X30
Catalog NumberFVHR20X30
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
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

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Device Identifiers

Device Issuing AgencyDevice ID
GS100837654352984 [Package]
Contains: 00850012832287
Package: [5 Units]
In Commercial Distribution
GS100850012832287 [Primary]
GS100850012832294 [Package]
Contains: 00850012832287
Package: Shipper Box Implant [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OXJMesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects

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 - Ventral Hernia Repair System]

00850012832348The Freedom™ Ventral Hernia Repair System consists of a synthetic and permanent polypropylene
00837654352991The Freedom™ Ventral Hernia Repair System consists of a synthetic and permanent polypropylene
00837654352984The Freedom™ Ventral Hernia Repair System consists of a synthetic and permanent polypropylene
00850012832256The Freedom™ Ventral Hernia Repair System consists of a synthetic and permanent polypropylene
00837654352960The Freedom™ Ventral Hernia Repair System consists of a synthetic and permanent polypropylene
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