Catalog Number

-

Brand Name

Megadyne

Version/Model Number

3110-10

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

5a424c8f-0976-426f-bd72-ccb089928a68

Public Version Date

December 31, 2021

Public Version Number

5

DI Record Publish Date

September 02, 2020

Package DI Number

30614559104525

Quantity per Package

20

Contains DI Package

10614559104521

Package Discontinue Date

December 31, 2021

Package Status

Not in Commercial Distribution

Package Type

-