Catalog Number

-

Brand Name

debritom+

Version/Model Number

2000.0004

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 31, 2021

Issuing Agency

In HIBCC

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

d118f2e7-960a-4709-b499-59b72052cb34

Public Version Date

March 31, 2021

Public Version Number

4

DI Record Publish Date

February 25, 2019

Package DI Number

B724200000041

Quantity per Package

5

Contains DI Package

B724200000040

Package Discontinue Date

March 31, 2021

Package Status

Not in Commercial Distribution

Package Type

-