Catalog Number

-

Brand Name

Ear Tip ET-12 Pack/250 pcs.

Version/Model Number

100126-250

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 23, 2020

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

ETT

Product Code Name

Cushion, Earphone (For Audiometric Testing)

Public Device Record Key

a453580b-8044-4424-8067-df141349b1d2

Public Version Date

June 24, 2020

Public Version Number

4

DI Record Publish Date

August 31, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-