Catalog Number

3343

Brand Name

3M™ Cavilon™

Version/Model Number

3343

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"

Yes

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

K955103,K955103,K955103

Product Code

KMF

Product Code Name

Bandage, liquid

Public Device Record Key

f188b176-eb3b-4fd6-90c9-c50a3c81779a

Public Version Date

October 25, 2018

Public Version Number

1

DI Record Publish Date

September 24, 2018

Package DI Number

50707387509748

Quantity per Package

4

Contains DI Package

30707387509744

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX