Catalog Number

E114 or E114X5

Brand Name

EXMOOR

Version/Model Number

E.114

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K911580,K911580,K911580

Product Code

ETD

Product Code Name

Tube, Tympanostomy

Public Device Record Key

2d867919-48d3-4979-9f77-b810a48645ce

Public Version Date

January 22, 2021

Public Version Number

4

DI Record Publish Date

September 20, 2018

Package DI Number

05060180251598

Quantity per Package

25

Contains DI Package

05060180256074

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

a box