Freedom - Ventral Hernia Repair System

Basic Information

• Brand Name: Freedom - Ventral Hernia Repair System
• Primary DI: 00850012832218
• Version / Model: FVHR12X15
• Catalog Number: FVHR12X15
• Company Name: INSIGHTRA MEDICAL, INC.
• Labeler DUNS: 097664937
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-07-22
• Public Version: 9
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 47cea81d-4a9c-4ac7-a1be-4301851f038d

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OXJ	Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects	General, Plastic Surgery	878.3300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44756	Extra-gynaecological surgical mesh, composite-polymer	A 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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00837654352960	GS1		5	Not in Commercial Distribution	2020-07-14
Primary	00850012832218	GS1
Package	00850012832232	GS1	Shipper Box Implant	5	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K142192	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			12X15