Catalog Number

-

Brand Name

STRADIS HEALTHCARE

Version/Model Number

ZZ-1408

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JEP

Product Code Name

Retainer, Matrix

Public Device Record Key

620e627b-071b-4fa4-ad96-15530b067839

Public Version Date

May 09, 2022

Public Version Number

1

DI Record Publish Date

April 29, 2022

Package DI Number

M752ZZ14081

Quantity per Package

10

Contains DI Package

M752ZZ14080

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE