Catalog Number

-

Brand Name

Ear Tip IT-01 Pack/50 pcs.

Version/Model Number

100898-50

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 22, 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

K133012,K133012

Product Code

ETT

Product Code Name

Cushion, Earphone (For Audiometric Testing)

Public Device Record Key

afdb2af2-ce35-44c6-a4a1-a8c15859275a

Public Version Date

June 23, 2020

Public Version Number

4

DI Record Publish Date

June 01, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-