Catalog Number

70-71784

Brand Name

DELTA

Version/Model Number

70-71784

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

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

K993061

Product Code

DZJ

Product Code Name

DRIVER, WIRE, AND BONE DRILL, MANUAL

Public Device Record Key

d98958d8-9be2-454f-899e-bcdcf9719cd5

Public Version Date

July 01, 2021

Public Version Number

5

DI Record Publish Date

August 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-