Catalog Number

-

Brand Name

SHEPARD GROMMET VENT TUBE WITH WIRE 102 MM ID FLUOROPLASTIC TWIN PACK

Version/Model Number

145702

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

-

Product Code

ETD

Product Code Name

Tube, Tympanostomy

Public Device Record Key

0f5d1405-68eb-45f0-b4fd-afc60db37fb6

Public Version Date

January 22, 2021

Public Version Number

3

DI Record Publish Date

October 24, 2015

Package DI Number

00821925017962

Quantity per Package

60

Contains DI Package

00821925038981

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-