Catalog Number

-

Brand Name

SHEPARD GROMMET VENT TUBE

Version/Model Number

525-043

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K062385,K062385

Product Code

ETD

Product Code Name

TUBE, TYMPANOSTOMY

Public Device Record Key

0d8c791c-6579-4dbb-8d6f-656f14cc2c65

Public Version Date

January 22, 2021

Public Version Number

6

DI Record Publish Date

February 18, 2016

Package DI Number

10844505008423

Quantity per Package

30

Contains DI Package

00844505008426

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-