Catalog Number

OS307202

Brand Name

ORTHO SOLUTIONS STERILE DRILL BITS

Version/Model Number

OS307202

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K102743

Product Code

HWE

Product Code Name

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

Public Device Record Key

674db298-5a2b-486a-8dfa-70d73270855c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 09, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-