Catalog Number

TRAA001S

Brand Name

Bulb Tip Yankauer — Vented

Version/Model Number

TRAA001S

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

c0ad4e02-a8d3-4ce3-a2e8-aa5595dd4e8a

Public Version Date

April 20, 2020

Public Version Number

3

DI Record Publish Date

July 31, 2018

Package DI Number

20848530086422

Quantity per Package

4

Contains DI Package

10848530086425

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-