Catalog Number

0700-040-001

Brand Name

NA

Version/Model Number

0700040001

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 25, 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

bf7038da-2eb7-49e2-a665-78b58393c43b

Public Version Date

August 30, 2021

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

34546540916816

Quantity per Package

10

Contains DI Package

04546540916815

Package Discontinue Date

March 25, 2021

Package Status

Not in Commercial Distribution

Package Type

pack