Catalog Number

-

Brand Name

Cytoplast™ Non-Resorbable PTFE Barrier Membranes, Titanium-Reinforced

Version/Model Number

Ti150XLK-2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LYC

Product Code Name

Bone Grafting Material, Synthetic

Public Device Record Key

4458f9bd-4188-46e2-9ba5-ddaa9b4f06bb

Public Version Date

December 07, 2020

Public Version Number

5

DI Record Publish Date

April 29, 2016

Package DI Number

D765TI150XLK21

Quantity per Package

2

Contains DI Package

D765TI150XLK20

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box