Catalog Number

-

Brand Name

Cytoplast™ Non-Resorbable PTFE Barrier Membranes

Version/Model Number

TXT1230

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

3b81ee43-dc7f-43c4-8086-294d741648e1

Public Version Date

January 10, 2022

Public Version Number

1

DI Record Publish Date

December 31, 2021

Package DI Number

D765TXT12301

Quantity per Package

10

Contains DI Package

D765TXT12300

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-