Catalog Number

-

Brand Name

Zavation Medical Products, LLC

Version/Model Number

540-742710

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

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

8ad0c7fc-0d33-4193-bc8a-fa9b101a4bda

Public Version Date

March 24, 2022

Public Version Number

2

DI Record Publish Date

November 02, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-