Catalog Number

6116

Brand Name

Curity

Version/Model Number

6116

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)

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

ca4e57ce-48ca-49e0-8f88-578b845ee651

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

June 30, 2018

Package DI Number

20884521068640

Quantity per Package

12

Contains DI Package

10884521068643

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK