Catalog Number

9102-10121406

Brand Name

SureMAX-X

Version/Model Number

1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K193359

Product Code

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Public Device Record Key

f9269d6e-b251-410f-8ee3-86995245d698

Public Version Date

May 06, 2020

Public Version Number

1

DI Record Publish Date

April 28, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-