Catalog Number

-

Brand Name

Stradis Medical, LLC.

Version/Model Number

10030-15

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

43f56b94-93a2-4f8d-9589-5316261e5b69

Public Version Date

June 09, 2022

Public Version Number

1

DI Record Publish Date

June 01, 2022

Package DI Number

M75210030151

Quantity per Package

1

Contains DI Package

M75210030150

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX