Catalog Number

-

Brand Name

Cytoplast™ Titanium-Reinforced PTFE Membranes

Version/Model Number

Ti250XLK-N-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

NPK

Product Code Name

Barrier, Synthetic, Intraoral

Public Device Record Key

df92488f-8676-4a14-b962-130473a0739d

Public Version Date

June 09, 2022

Public Version Number

1

DI Record Publish Date

June 01, 2022

Package DI Number

D765TI250XLKN21

Quantity per Package

2

Contains DI Package

D765TI250XLKN20

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-