Catalog Number

CS6125

Brand Name

Sonoma Orthopedic Products, Inc

Version/Model Number

2.5mm Syndesmotic Drill

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 07, 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

965bf4f0-23e4-439c-a8d9-a8bd4e33de0d

Public Version Date

July 08, 2020

Public Version Number

3

DI Record Publish Date

August 19, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-