Catalog Number

52-02210

Brand Name

NA

Version/Model Number

52-02210

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)

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

b83bb389-87db-4611-a5ad-09fdb3929a5c

Public Version Date

September 16, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2018

Package DI Number

37613154646976

Quantity per Package

2

Contains DI Package

07613154646975

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack