Catalog Number

S2713.098.

Brand Name

Drill Bit

Version/Model Number

S2713.098.YJ

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

GFF

Product Code Name

Bur, Surgical, General & Plastic Surgery

Public Device Record Key

9aca8f82-2d7e-46bd-8b27-11005f664d5c

Public Version Date

September 05, 2022

Public Version Number

1

DI Record Publish Date

August 26, 2022

Package DI Number

24053613281038

Quantity per Package

1

Contains DI Package

14053613281031

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-