Catalog Number

-

Brand Name

BURR GUIDE 4 LEG 10X8

Version/Model Number

18296

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

K072298

Product Code

FZX

Product Code Name

Guide, Surgical, Instrument

Public Device Record Key

2bd89ee4-37a3-40df-98aa-472b4f79bee7

Public Version Date

August 09, 2019

Public Version Number

2

DI Record Publish Date

June 06, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-