Catalog Number

LX420R

Brand Name

AESCULAP

Version/Model Number

LX420R

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 11, 2021

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)

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

91a9a214-63d3-4ceb-ab0e-88049fab4267

Public Version Date

May 28, 2021

Public Version Number

2

DI Record Publish Date

April 20, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-