Catalog Number

CS6120

Brand Name

Sonoma Orthopedic Products, Inc

Version/Model Number

2.0mm Drill Fibulock

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 08, 2020

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

37b98aae-1422-4f7c-8b3c-88961e00032e

Public Version Date

July 09, 2020

Public Version Number

4

DI Record Publish Date

September 13, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-