Catalog Number

-

Brand Name

INTERFACE WHITE

Version/Model Number

7101

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K897130

Product Code

EJK

Product Code Name

Liner, Cavity, Calcium Hydroxide

Public Device Record Key

651bddc2-3959-44ff-9659-1e69e0860955

Public Version Date

February 05, 2020

Public Version Number

1

DI Record Publish Date

January 28, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-