Catalog Number

-

Brand Name

Reprocessed Acutrak 2 Standard System, Cannulated Drill Bit, Long

Version/Model Number

AT2M-L1813

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

HTW

Product Code Name

Bit, Drill

Public Device Record Key

df560dc0-3f8b-4e3e-b806-ef00220be309

Public Version Date

June 30, 2021

Public Version Number

1

DI Record Publish Date

June 22, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-