Last synced on 27 January 2023 at 11:04 pm

Inhibitor, Postoperative Fibrosis (Spine Adhesion Barrier)

Page Type
Product Code
Definition
Intended for use as a mechanical barrier to adhesion formation.
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. A syringe and applicator are provided to deliver the gel.
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
Neural tissues in the spine.
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 PCQ is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.

Inhibitor, Postoperative Fibrosis (Spine Adhesion Barrier)

Page Type
Product Code
Definition
Intended for use as a mechanical barrier to adhesion formation.
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. A syringe and applicator are provided to deliver the gel.
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
Neural tissues in the spine.
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 PCQ is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.