Catalog Number

-

Brand Name

Cytoplast™ Non-Resorbable PTFE Barrier Membranes

Version/Model Number

TXT2530

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

Labeling does not contain MRI Safety Information

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

8913eabf-b42d-4b7a-9086-01c65b0e73e4

Public Version Date

December 07, 2020

Public Version Number

5

DI Record Publish Date

April 29, 2016

Package DI Number

D765TXT25301

Quantity per Package

4

Contains DI Package

D765TXT25300

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box