Catalog Number

317335

Brand Name

NA

Version/Model Number

317.335

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

K043310

Product Code

DZI

Product Code Name

DRILL, BONE, POWERED

Public Device Record Key

27918ec3-d0dd-4e4f-a3a6-f8352b583d14

Public Version Date

April 25, 2022

Public Version Number

3

DI Record Publish Date

September 21, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-