Catalog Number

2224/A

Brand Name

VertecoR®

Version/Model Number

00884450296325

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

HTW

Product Code Name

BIT, DRILL

Public Device Record Key

76951369-b2d5-46af-a1fa-564fab6861d0

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 16, 2018

Package DI Number

10884450296322

Quantity per Package

75

Contains DI Package

00884450296325

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-