Catalog Number

-

Brand Name

STRADIS HEALTHCARE

Version/Model Number

ZZ-1410

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 28, 2022

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

OFX

Product Code Name

General Purpose Dental Tray

Public Device Record Key

6e35bb03-553d-4e15-a890-099fde9b1864

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

April 27, 2022

Package DI Number

M752ZZ14101

Quantity per Package

10

Contains DI Package

M752ZZ14100

Package Discontinue Date

May 28, 2022

Package Status

Not in Commercial Distribution

Package Type

CASE