Catalog Number

ZB-K004

Brand Name

AccuPlan® System

Version/Model Number

ZB-K004

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

-

Product Code

DZJ

Product Code Name

Driver, Wire, And Bone Drill, Manual

Public Device Record Key

471ff7cd-d9d0-4a86-a2f9-d85c2098b22f

Public Version Date

May 13, 2022

Public Version Number

1

DI Record Publish Date

May 05, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-