Catalog Number

-

Brand Name

NA

Version/Model Number

VA-1100

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"

Yes

For Single-Use

-

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

JZF

Product Code Name

Tube, Ear Suction

Public Device Record Key

4945fe2a-14f0-4046-988e-8c57e5ef1708

Public Version Date

August 23, 2021

Public Version Number

6

DI Record Publish Date

September 12, 2016

Package DI Number

10385640000519

Quantity per Package

5

Contains DI Package

00385640000512

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box