Catalog Number

TST-SNTP

Brand Name

ACUTIPS

Version/Model Number

TST-SNTP

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

b44fdb36-bfa2-431f-803c-c078d1f90b67

Public Version Date

January 14, 2022

Public Version Number

1

DI Record Publish Date

January 06, 2022

Package DI Number

D832TSTSNTPB1

Quantity per Package

1500

Contains DI Package

D832TSTSNTP1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box