Catalog Number

-

Brand Name

UltraMIST Single Use Applicator (12 Pack)

Version/Model Number

CP-80040

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K140782

Product Code

NRB

Product Code Name

Wound Cleaner, Ultrasound

Public Device Record Key

33066371-c786-4684-8659-7586ef76b19f

Public Version Date

February 02, 2021

Public Version Number

1

DI Record Publish Date

January 25, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-