Catalog Number

3337

Brand Name

Curity

Version/Model Number

3337

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 18, 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

c42b4d9d-8182-4486-9441-a04f5b096b10

Public Version Date

October 12, 2020

Public Version Number

5

DI Record Publish Date

June 30, 2018

Package DI Number

20884521068299

Quantity per Package

48

Contains DI Package

10884521068292

Package Discontinue Date

October 18, 2019

Package Status

Not in Commercial Distribution

Package Type

PACK_OR_INNER_PACK