Catalog Number

-

Brand Name

Ear Tip IT-01 Pack/100 pcs.

Version/Model Number

100898-100

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)

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

f62b17ac-9ee6-48d0-b528-f567f41236ea

Public Version Date

September 24, 2019

Public Version Number

3

DI Record Publish Date

June 01, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-