Catalog Number

1271-284

Brand Name

VIRGINIA ROARING BURR

Version/Model Number

1271-284

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 13, 2021

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)

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

43b6704c-c8a8-4edc-be72-0a066b78eb54

Public Version Date

May 14, 2021

Public Version Number

2

DI Record Publish Date

September 27, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-