Catalog Number

-

Brand Name

FEUERSTEIN SPLIT TUBE 114 MM ID 6 MM LENGTH FLUOROPLASTIC

Version/Model Number

900020-ENT

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

K992222,K992222

Product Code

ETD

Product Code Name

Tube, Tympanostomy

Public Device Record Key

5795f82f-6e84-4444-b018-4ef4648e05a3

Public Version Date

January 22, 2021

Public Version Number

4

DI Record Publish Date

October 24, 2015

Package DI Number

00821925023949

Quantity per Package

6

Contains DI Package

00821925039810

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-