Catalog Number

ST6900

Brand Name

Sonoma Orthopedic Products, Inc.

Version/Model Number

Fibulock Disposable Removal Kit

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

HSB

Product Code Name

Rod, Fixation, Intramedullary And Accessories

Public Device Record Key

069e9326-47bb-4742-97c1-030b0664207b

Public Version Date

July 09, 2020

Public Version Number

7

DI Record Publish Date

November 24, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-