Catalog Number

TST-MT

Brand Name

ACUTIPS

Version/Model Number

TST-MT

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

DYN

Product Code Name

Mouthpiece, Saliva Ejector

Public Device Record Key

1e790ea1-4936-4ded-a69d-9ac1d2fdd046

Public Version Date

August 03, 2022

Public Version Number

2

DI Record Publish Date

January 06, 2022

Package DI Number

D832TSTMTB1

Quantity per Package

1600

Contains DI Package

D832TSTMT0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box