Catalog Number

0935-0-054

Brand Name

INSTRUMENT

Version/Model Number

0935-0-054

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

03408858-7a0e-4163-b2d6-0c517a0e4f5e

Public Version Date

July 10, 2018

Public Version Number

3

DI Record Publish Date

December 01, 2016

Package DI Number

07613327261059

Quantity per Package

5

Contains DI Package

17613327261056

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack