Catalog Number

CS-TD-12

Brand Name

TD-12®

Version/Model Number

TD-12

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

K192228

Product Code

MED

Product Code Name

Sterilant, Medical Devices

Public Device Record Key

f1718967-e62a-4e8e-bbd5-e0be61689bfb

Public Version Date

March 19, 2021

Public Version Number

4

DI Record Publish Date

April 15, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-