Catalog Number

-

Brand Name

Megadyne

Version/Model Number

3110-09EC

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2021

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

FYD

Product Code Name

APPARATUS, EXHAUST, SURGICAL

Public Device Record Key

3fc4fca6-69f7-4258-a75f-39e9598a0b6e

Public Version Date

December 31, 2021

Public Version Number

8

DI Record Publish Date

December 14, 2016

Package DI Number

30614559102996

Quantity per Package

20

Contains DI Package

10614559102992

Package Discontinue Date

December 31, 2021

Package Status

Not in Commercial Distribution

Package Type

-