Catalog Number

6189-03

Brand Name

8mm Angled Curette

Version/Model Number

6189-03

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 23, 2016

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

987e9a76-738c-4adb-a6d8-4884f250ec55

Public Version Date

May 07, 2019

Public Version Number

3

DI Record Publish Date

September 21, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-