Catalog Number

FSS-01-0500T

Brand Name

FloShield/Air

Version/Model Number

FSS-01-0500T

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"

Yes

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

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Public Device Record Key

9ef30e6d-2a49-4c5a-871a-0652cd306901

Public Version Date

April 09, 2019

Public Version Number

3

DI Record Publish Date

July 25, 2016

Package DI Number

10815128020000

Quantity per Package

6

Contains DI Package

00815128020003

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Sales Box