Catalog Number

-

Brand Name

STRADIS HEALTHCARE

Version/Model Number

MPR961

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

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Public Device Record Key

9ce9f96a-38ee-4201-863e-1b4356ae484f

Public Version Date

April 01, 2022

Public Version Number

2

DI Record Publish Date

March 02, 2022

Package DI Number

M752MPR9611

Quantity per Package

100

Contains DI Package

M752MPR9610

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE