Catalog Number

3339

Brand Name

Curity

Version/Model Number

3339

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 14, 2019

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KMF

Product Code Name

Bandage, liquid

Public Device Record Key

48fd9eb7-4712-4221-ab8c-6c4d0d85ce91

Public Version Date

October 12, 2020

Public Version Number

5

DI Record Publish Date

June 27, 2018

Package DI Number

20884527016669

Quantity per Package

96

Contains DI Package

10884527016662

Package Discontinue Date

November 14, 2019

Package Status

Not in Commercial Distribution

Package Type

CASE