Catalog Number

31106801S

Brand Name

NA

Version/Model Number

311.068.01S

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K153587

Product Code

HBG

Product Code Name

DRILLS, BURRS, TREPHINES & ACCESSORIES (MANUAL)

Public Device Record Key

c15c6106-7154-40b4-9256-08df980e3271

Public Version Date

April 25, 2022

Public Version Number

4

DI Record Publish Date

April 20, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-