Catalog Number

-

Brand Name

Paparella

Version/Model Number

24451

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

-

Product Code

ETD

Product Code Name

TUBE, TYMPANOSTOMY

Public Device Record Key

0a2b92fe-71c4-4eb6-8f25-a5d75e3ddba5

Public Version Date

January 22, 2021

Public Version Number

3

DI Record Publish Date

July 06, 2015

Package DI Number

20681490062699

Quantity per Package

5

Contains DI Package

00681490062695

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK