FDA.reportPublic FDA data

Freedom - Ventral Hernia Repair System

Primary DI
00850012832256
Brand
Freedom - Ventral Hernia Repair System
Company
INSIGHTRA MEDICAL, INC.
Model
FVHR15X25
Catalog number
FVHR15X25
Device description
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.
Published
2015-07-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OXJMesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OXJMesh, Surgical, Non-Absorbable, Large Abdominal Wall DefectsGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142192000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142192000Insightra Freedom Ventral Hernia Repair SystemInsightra Medical2015-05-07FTL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00837654352977PackageGS15In Commercial Distribution
00850012832263PackageGS15In Commercial Distribution
00850012832256PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00837654352977008376543529778376543529770837654352977
00850012832263008500128322638500128322630850012832263
00850012832256008500128322568500128322560850012832256

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal hernia surgical mesh, composite-polymerA sterile, flat, or three-dimensional (3-D), woven/knitted material made of two or more polymers that includes a bioabsorbable polymer [e.g., polyglycolic acid (PGA)] and a non-bioabsorbable polymer [e.g., polyethylene (PE)] intended to be permanently implanted for abdominal hernia (e.g., inguinal, ventral/incisional, umbilical, femoral) and fascial defect repair/reinforcement applications, and excludes devices designed specifically for diaphragmatic hernia repair. It may also be used as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
949-215-1835raqa@insightra.com
931-919-2955raqa@insightra.com

Regulatory Flags#

DUNS number
097664937
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00013964672237Modulare Stabilization DeviceM-CVC/PICCSP2015-03-16
00013964672077Modulare Stabilization DeviceM-CVC/PICC2015-03-16
00850012832010Freedom - ProFlor Inguinal Hernia ImplantFIHR 25mmFIHR 25mm2015-07-22
00850012832072Freedom - ProFlor Inguinal Hernia ImplantFIHR 40mmFIHR 40mm2015-07-22
00850012832102Freedom - ProFlor Inguinal Hernia ImplantFIHR 40mmEFIHR 40mmE2015-07-22
00850012832218Freedom - Ventral Hernia Repair SystemFVHR12X15FVHR12X152015-07-22
00850012832287Freedom - Ventral Hernia Repair SystemFVHR20X30FVHR20X302015-07-22
00850012832317Freedom - Ventral Hernia Repair SystemFVHR28X35FVHR28X352015-07-22
00850012832041Freedom - ProFlor Inguinal Hernia ImplantFIHR 25mmEFIHR 25mmE2015-07-22
00850012832348Freedom - Ventral Hernia Repair SystemFVHR35X45FVHR35X452015-07-22
00013964672152Freedom - ProFlor Inguinal Hernia KitFIHR 40mmEKFIHR 40mmEK2015-07-22
00013964672367Freedom - ProFlor Inguinal Hernia KitFIHR 25mmEKFIHR 25mmEK2015-07-22
00837654352878Freedom - ProFlor Inguinal Hernia KitFIHR 25mmKFIHR 25mmK2015-07-22
00837654352885Freedom - ProFlor Inguinal Hernia KitFIHR 40mmKFIHR 40mmK2015-07-22
17350021986129PowerPumpTM dp System Day Cassette9410122016-09-24
17350021986136PowerPumpTM dp System Patient cassette9410132016-09-24
17350021986143PowerPumpTM dp System Patient tubing9410142016-09-24
07350021981004Double Pump Day cassette/ Double Pump RF Day cassette10020532016-09-24
07350021981509Double Pump Single/ Double Pump RF Single10020522016-09-24
07350021982001Double Pump Patient cassette10020592016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04042301097583Ti-MESHpfm medical titanium gmbhOXJ2021-11-01
04042301097620Ti-MESHpfm medical titanium gmbhOXJ2021-11-01
04042301102768Ti-MESHpfm medical titanium gmbhOXJ2021-11-01
04042301117397Ti-MESHpfm medical titanium gmbhOXJ2021-11-01
04042301117786Ti-MESHpfm medical titanium gmbhOXJ2021-11-01
04042301117809Ti-MESHpfm medical titanium gmbhOXJ2021-11-01
04042301097606TiMESHpfm medical titanium gmbhOXJ2020-06-02
04042301097545TiMESHpfm medical titanium gmbhOXJ2019-12-09
04042301097569TiMESHpfm medical titanium gmbhOXJ2019-12-09
04042301097644TiMESHpfm medical titanium gmbhOXJ2019-12-09
04042301144317TiMESHpfm medical titanium gmbhOXJ2019-12-09
04042301144331TiMESHpfm medical titanium gmbhOXJ2019-12-09
04042301097552TiMESHpfm medical titanium gmbhOXJ2019-12-09
04042301097576TiMESHpfm medical titanium gmbhOXJ2019-12-09
04042301097651TiMESHpfm medical titanium gmbhOXJ2019-12-09
04042301097668TiMESHpfm medical titanium gmbhOXJ2019-12-09
04042301144324TiMESHpfm medical titanium gmbhOXJ2019-12-09
04042301144348TiMESHpfm medical titanium gmbhOXJ2019-12-09
EBCBMFP1320TiO2MeshBioCer Entwicklungs-GmbHOXJ2018-03-15
EBCBMFP1330TiO2MeshBioCer Entwicklungs-GmbHOXJ2018-03-15
EBCBMFP1410TiO2MeshBioCer Entwicklungs-GmbHOXJ2018-03-15
EBCEMFP1310TiO2MeshBioCer Entwicklungs-GmbHOXJ2018-03-15
03700296903265SURGIMESH®XBASPIDE MEDICALOXJ2015-10-23
03700296903272SURGIMESH®XBASPIDE MEDICALOXJ2015-10-23
03700296903289SURGIMESH®XBASPIDE MEDICALOXJ2015-10-23
03700296903296SURGIMESH®XBASPIDE MEDICALOXJ2015-10-23
00850012832218Freedom - Ventral Hernia Repair SystemINSIGHTRA MEDICAL, INC.OXJ2015-07-22
00850012832287Freedom - Ventral Hernia Repair SystemINSIGHTRA MEDICAL, INC.OXJ2015-07-22
00850012832317Freedom - Ventral Hernia Repair SystemINSIGHTRA MEDICAL, INC.OXJ2015-07-22
00837654352960Freedom - Ventral Hernia Repair SystemINSIGHTRA MEDICAL, INC.OXJ2015-07-22