Catalog Number

-

Brand Name

Reprocessed 0.7mm Diamond Bur

Version/Model Number

951-95-007

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

HTT

Product Code Name

Burr, Orthopedic

Public Device Record Key

98826e7e-8331-44f4-872f-e1a7c96e6401

Public Version Date

October 12, 2021

Public Version Number

1

DI Record Publish Date

October 04, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-