Catalog Number

2555J

Brand Name

MEGADYNE

Version/Model Number

2555J

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

K200250,K200250,K200250

Product Code

FYD

Product Code Name

APPARATUS, EXHAUST, SURGICAL

Public Device Record Key

003b5647-fef4-4c7f-94cc-ae6958a84e97

Public Version Date

June 11, 2021

Public Version Number

6

DI Record Publish Date

August 14, 2020

Package DI Number

30614559104563

Quantity per Package

10

Contains DI Package

10614559104569

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX