Catalog Number

222-2066

Brand Name

OsteoMed

Version/Model Number

222-2066

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

-

Product Code

HBE

Product Code Name

DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Public Device Record Key

1bc711eb-8c2e-4250-b590-6d9e1e008279

Public Version Date

September 16, 2022

Public Version Number

6

DI Record Publish Date

October 26, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-