Catalog Number

-

Brand Name

Cavios

Version/Model Number

―

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K111668

Product Code

EJK

Product Code Name

Liner, Cavity, Calcium Hydroxide

Public Device Record Key

a6fb04cd-aae3-4f73-b84b-5cae8de68817

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

April 16, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-