Catalog Number

CSR60

Brand Name

NA

Version/Model Number

CSR60

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

K960630

Product Code

HBB

Product Code Name

MOTOR, DRILL, PNEUMATIC

Public Device Record Key

7cadd25d-2229-40f8-8622-a75e79361179

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 05, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-