Catalog Number

-

Brand Name

Typhoon

Version/Model Number

SA3H11B11DUS1

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FLH

Product Code Name

Washer Of Body Waste Receptacles

Public Device Record Key

2fb6cd29-b68c-4f1d-a305-e31285977d68

Public Version Date

August 11, 2022

Public Version Number

1

DI Record Publish Date

August 03, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-