Catalog Number

CTR-02

Brand Name

Plasdent

Version/Model Number

CTR-02

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NAB

Product Code Name

Gauze / Sponge,Nonresorbable For External Use

Public Device Record Key

a6201f9b-8c4d-4071-bfdd-d3341559cb32

Public Version Date

April 01, 2022

Public Version Number

1

DI Record Publish Date

March 24, 2022

Package DI Number

D832CTR022

Quantity per Package

12

Contains DI Package

D832CTR021

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case