Catalog Number

P30-127

Brand Name

De Soutter Medical

Version/Model Number

P30-127

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

-

Product Code

FQH

Product Code Name

Lavage, Jet

Public Device Record Key

8f6f0c85-6e77-4ee3-85a4-dc6e500f0fbe

Public Version Date

October 28, 2022

Public Version Number

2

DI Record Publish Date

October 10, 2022

Package DI Number

15051471189123

Quantity per Package

5

Contains DI Package

05051471189126

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box