Catalog Number

200-271

Brand Name

ACRA-CUT

Version/Model Number

14/11mm DGR-O

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

HBF

Product Code Name

Drills, Burrs, Trephines & Accessories (Compound, Powered)

Public Device Record Key

09c3d37b-b160-4749-8651-48ee4f3192c3

Public Version Date

November 22, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-