Catalog Number

PRO8500SB

Brand Name

HALL MICROFREE MINIDRIVER

Version/Model Number

PRO8500SB

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 21, 2020

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

-

Product Code

HAB

Product Code Name

SAW, POWERED, AND ACCESSORIES

Public Device Record Key

e5718edb-7c56-48b0-a9da-ff2acc5a37fc

Public Version Date

September 21, 2020

Public Version Number

4

DI Record Publish Date

January 15, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-