Catalog Number

-

Brand Name

Ear Tip IT-02 Pack/250 pcs.

Version/Model Number

100899-250

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

K133012,K133012

Product Code

ETT

Product Code Name

Cushion, Earphone (For Audiometric Testing)

Public Device Record Key

b6ea05c8-e4ce-47b3-a93e-bfcbdeabdad3

Public Version Date

June 24, 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

-