Catalog Number

-

Brand Name

RapidVac

Version/Model Number

SEA3710

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

K980915,K980915

Product Code

FYD

Product Code Name

APPARATUS, EXHAUST, SURGICAL

Public Device Record Key

d3f04a05-7e88-4a92-a6df-6fb8c4c30f45

Public Version Date

October 05, 2022

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

10884524000879

Quantity per Package

10

Contains DI Package

20884524000876

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE