← Back to catalogue

Freedom - Ventral Hernia Repair System

FDA UDI

Class II (US FDA UDI)

by Insightra Medical, Inc.

Identity

Trade Name
Freedom - Ventral Hernia Repair System FDA UDI
Generic Name
Extra-gynaecological surgical mesh, composite-polymer FDA UDI
Device Name
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. FDA UDI
Model / Reference
FVHR20X30 FDA UDI
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. FDA UDI

Identifiers

Catalog Number
FVHR20X30 FDA UDI
Primary DI / UDI-DI
00850012832287 FDA UDI
510(k) Number
K142192 FDA UDI
FDA Product Code
OXJ FDA UDI
GMDN Term
Extra-gynaecological surgical mesh, composite-polymer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.3300 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Extra-gynaecological surgical mesh, composite-polymer

Freedom - Ventral Hernia Repair System by Insightra Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Extra-gynaecological surgical mesh, composite-polymer.

Cleared under the same submission

K142192 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Insightra Medical, Inc.

Sources (1)

  • FDA UDI 00907cd2-08cf-4e27-b725-24a44739dbfa 37 fields · synced Jun 8, 2026