Catalog Number

-

Brand Name

NA

Version/Model Number

IRC400

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

K012453

Product Code

HBC

Product Code Name

MOTOR, DRILL, ELECTRIC

Public Device Record Key

7a0a98b3-235c-486b-b6b3-9cf71f3e410f

Public Version Date

November 22, 2018

Public Version Number

4

DI Record Publish Date

July 04, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-