Catalog Number

TRAA002S

Brand Name

Sunset Bulb Tip Yankauer - Non-Vented

Version/Model Number

TRAA002S

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

GCX

Product Code Name

Apparatus, Suction, Operating-Room, Wall Vacuum Powered

Public Device Record Key

dac6efae-99e4-4fc3-aa50-b6d22828b643

Public Version Date

April 20, 2020

Public Version Number

3

DI Record Publish Date

September 17, 2018

Package DI Number

20848530086439

Quantity per Package

4

Contains DI Package

10848530086432

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-