Catalog Number

DF900010

Brand Name

DOLPHIX

Version/Model Number

Drill brace

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K163323

Product Code

JDW

Product Code Name

Pin, Fixation, Threaded

Public Device Record Key

0d2e5615-c159-46f4-84e1-6b1d3d2144b7

Public Version Date

September 20, 2021

Public Version Number

4

DI Record Publish Date

June 19, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-