Catalog Number

-

Brand Name

Contour Healer

Version/Model Number

Nobel ™ Conical Connection Compatible 4.3/5.0 mm

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K112099

Product Code

NAH

Product Code Name

System, Test, Tumor Marker, For Detection Of Bladder Cancer

Public Device Record Key

a8069ccb-311d-4d4d-84cd-0a36aa5fa477

Public Version Date

December 07, 2018

Public Version Number

2

DI Record Publish Date

September 07, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-