Catalog Number

E.1011

Brand Name

EXMOOR

Version/Model Number

E.1011

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 27, 2019

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K911580,K911580

Product Code

ETD

Product Code Name

Tube, Tympanostomy

Public Device Record Key

114dd646-b5be-43bc-a0bf-308e9a232ed8

Public Version Date

January 22, 2021

Public Version Number

3

DI Record Publish Date

September 20, 2018

Package DI Number

05060180251413

Quantity per Package

5

Contains DI Package

05060180255893

Package Discontinue Date

August 27, 2019

Package Status

Not in Commercial Distribution

Package Type

a box