Catalog Number

-

Brand Name

STRADIS HEALTHCARE

Version/Model Number

ZZ-0695

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"

Yes

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

HTD

Product Code Name

Forceps

Public Device Record Key

96f23e3c-0cea-4171-8ecf-e19210113366

Public Version Date

May 05, 2022

Public Version Number

1

DI Record Publish Date

April 27, 2022

Package DI Number

M752ZZ06951

Quantity per Package

25

Contains DI Package

M752ZZ06950

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE