Last synced on 23 September 2022 at 11:05 pm

Inhibitor, Postoperative Fibrosis (Adhesion Barrier)

Page Type
Product Code
Definition
The device is designed to coat surfaces exposed in tendon and peripheral nerve surgery, in order to form a temporary mechanical barrier that separates tissues for the purpose of reducing fibrosis and reducing the formation of adhesions.
Physical State
The gel is a sterile, absorbable, isotonic combination of sodium carboxymethylcellulose (CMC) and polyethylene oxide (PEO) with calcium chloride and sodium chloride in sterile water for injection.
Technical Method
The product is applied to coat the surgically traumatized tissue and surrounding area. The gel remains at the site of application for a period of time, providing a barrier to adhesion formation during the healing process. The material is absorbed. It does not require a second operation for removal.
Target Area
The product is designed to coat surfaces exposed in tendon and peripheral nerve surgery, in order to form a temporary mechanical barrier that separates tissues.
Review Panel
Neurology
Submission Type
Contact ODE
Device Classification
N
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code OZJ is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.

Inhibitor, Postoperative Fibrosis (Adhesion Barrier)

Page Type
Product Code
Definition
The device is designed to coat surfaces exposed in tendon and peripheral nerve surgery, in order to form a temporary mechanical barrier that separates tissues for the purpose of reducing fibrosis and reducing the formation of adhesions.
Physical State
The gel is a sterile, absorbable, isotonic combination of sodium carboxymethylcellulose (CMC) and polyethylene oxide (PEO) with calcium chloride and sodium chloride in sterile water for injection.
Technical Method
The product is applied to coat the surgically traumatized tissue and surrounding area. The gel remains at the site of application for a period of time, providing a barrier to adhesion formation during the healing process. The material is absorbed. It does not require a second operation for removal.
Target Area
The product is designed to coat surfaces exposed in tendon and peripheral nerve surgery, in order to form a temporary mechanical barrier that separates tissues.
Review Panel
Neurology
Submission Type
Contact ODE
Device Classification
N
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code OZJ is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.