Catalog Number

SPD2.3

Brand Name

Swish™ Straight Drill (6-16mmL)

Version/Model Number

SPD2.3

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

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

K081396

Product Code

DZI

Product Code Name

Drill, Bone, Powered

Public Device Record Key

fbc593ff-f376-4847-ab37-8a9b8c481379

Public Version Date

November 22, 2018

Public Version Number

4

DI Record Publish Date

September 23, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-