Catalog Number

-

Brand Name

Premium Plus

Version/Model Number

T-M222RD

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

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

-

Product Code

EHK

Product Code Name

Cup, Prophylaxis

Public Device Record Key

4703a810-29fa-4558-a913-5ede67b2a2d1

Public Version Date

January 10, 2020

Public Version Number

1

DI Record Publish Date

January 02, 2020

Package DI Number

D838TM222RD8

Quantity per Package

10

Contains DI Package

D838TM222RD6

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE