Catalog Number

-

Brand Name

Summit Medical

Version/Model Number

VT-1002-01

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

K830228,K830228

Product Code

ETD

Product Code Name

Tube, Tympanostomy

Public Device Record Key

21bf1d47-0c88-4d9e-aea2-3f759cd8b9bf

Public Version Date

October 14, 2022

Public Version Number

1

DI Record Publish Date

October 06, 2022

Package DI Number

10385640068960

Quantity per Package

10

Contains DI Package

00385640068963

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

SHELF BOX