FDA.reportPublic FDA data

Freedom - Ventral Hernia Repair System

Primary DI
00850012832218
Brand
Freedom - Ventral Hernia Repair System
Company
INSIGHTRA MEDICAL, INC.
Model
FVHR12X15
Catalog number
FVHR12X15
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 and 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
00837654352960PackageGS15Not in Commercial Distribution
00850012832232PackageGS15In Commercial Distribution
00850012832218PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00837654352960008376543529608376543529600837654352960
00850012832232008500128322328500128322320850012832232
00850012832218008500128322188500128322180850012832218

GMDN Terms#

Term, Definition table
TermDefinition
Extra-gynaecological surgical mesh, composite-polymerA partially-bioabsorbable, implantable material (e.g., flat sheet) 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 for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. It may also be intended as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation may be supplied with the mesh.

Device Sizes#

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

Contacts#

Phone, Email table
PhoneEmail
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
00850012832287Freedom - Ventral Hernia Repair SystemFVHR20X30FVHR20X302015-07-22
00850012832317Freedom - Ventral Hernia Repair SystemFVHR28X35FVHR28X352015-07-22
00850012832041Freedom - ProFlor Inguinal Hernia ImplantFIHR 25mmEFIHR 25mmE2015-07-22
00850012832256Freedom - Ventral Hernia Repair SystemFVHR15X25FVHR15X252015-07-22
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
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
00850012832256Freedom - Ventral Hernia Repair SystemINSIGHTRA MEDICAL, INC.OXJ2015-07-22