Catalog Number

22-1020

Brand Name

N/A

Version/Model Number

22-1020

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

b4ed4a38-0d06-4202-88af-7e0f45f07f70

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

August 30, 2015

Package DI Number

20817470008528

Quantity per Package

10

Contains DI Package

00817470008524

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX