Catalog Number

OSS-8361

Brand Name

ORTHO SOLUTIONS STERILE DRILL BITS

Version/Model Number

OSS-8361

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

K102743,K102743

Product Code

HWE

Product Code Name

Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Public Device Record Key

fb512008-be76-4fcc-ba2a-ec0174f99d50

Public Version Date

January 22, 2021

Public Version Number

4

DI Record Publish Date

January 23, 2017

Package DI Number

05055662942286

Quantity per Package

5

Contains DI Package

05055662942293

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cardboard Box