Catalog Number

-

Brand Name

debritom+

Version/Model Number

2000.0200

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

45ceaa2c-d262-4f69-bb67-9d9ea98b0369

Public Version Date

September 17, 2021

Public Version Number

1

DI Record Publish Date

September 09, 2021

Package DI Number

07649996166081

Quantity per Package

5

Contains DI Package

07649996166074

Package Discontinue Date

April 30, 2021

Package Status

Not in Commercial Distribution

Package Type

-