Catalog Number

2460.00

Brand Name

STOMA®

Version/Model Number

2460.00

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code

EKH

Product Code Name

CARVER, DENTAL AMALGAM, OPERATIVE

Public Device Record Key

b1080583-d90d-4813-9302-15b3cb69d70f

Public Version Date

September 22, 2020

Public Version Number

2

DI Record Publish Date

August 27, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-