Catalog Number

1.94.20

Brand Name

ENDO-EAR

Version/Model Number

1.94.20

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 29, 2019

Issuing Agency

In HIBCC

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

-

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

JZF

Product Code Name

Tube, Ear Suction

Public Device Record Key

5cf0a3cf-5087-4e0d-af37-8dcc0c1fb7de

Public Version Date

April 20, 2020

Public Version Number

2

DI Record Publish Date

January 29, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-