FDA.reportPublic FDA data

Freedom - Ventral Hernia Repair System

Primary DI
00850012832287
Brand
Freedom - Ventral Hernia Repair System
Company
INSIGHTRA MEDICAL, INC.
Model
FVHR20X30
Catalog number
FVHR20X30
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
00837654352984PackageGS15Not in Commercial Distribution
00850012832294PackageGS15In Commercial Distribution
00850012832287PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00837654352984008376543529848376543529840837654352984
00850012832294008500128322948500128322940850012832294
00850012832287008500128322878500128322870850012832287

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
00850012832218Freedom - Ventral Hernia Repair SystemFVHR12X15FVHR12X152015-07-22
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
00850012832218Freedom - 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