Catalog Number

SPD5.1

Brand Name

Swish™ Straight Drill (6-16mmL)

Version/Model Number

SPD5.1

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

7fc6957e-4af5-43bf-ab17-040a9cc04dcc

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

-