Catalog Number

-

Brand Name

PRETTAU 3 Dispersive B1 95H18

Version/Model Number

ZROC8041B01

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

EIH

Product Code Name

POWDER, PORCELAIN

Public Device Record Key

8f7c8043-997b-4ba9-9f1f-18a9bea84616

Public Version Date

January 25, 2021

Public Version Number

1

DI Record Publish Date

January 15, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-