Catalog Number

401063

Brand Name

PlusDrive

Version/Model Number

401.063

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

K162594,K963546,K170818,K162594,K102656,K963546,K170818,K102656

Product Code

DZL

Product Code Name

SCREW, FIXATION, INTRAOSSEOUS

Public Device Record Key

c9c20416-1a13-4ee2-ac83-e4d95cccc632

Public Version Date

July 12, 2022

Public Version Number

4

DI Record Publish Date

September 14, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-