Catalog Number

CS1635-CN

Brand Name

Sonoma Orthopedic Products, Inc.

Version/Model Number

3.5mm Cannulated Reamer, Non-Sterile

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

HTO

Product Code Name

Reamer

Public Device Record Key

417a552f-e448-40dc-8fe3-c35649a2a701

Public Version Date

July 09, 2020

Public Version Number

6

DI Record Publish Date

January 28, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-