Catalog Number

315.330.EM

Brand Name

EMERGE MEDICAL & Design

Version/Model Number

315.330.EM

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 01, 2018

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

HTW

Product Code Name

BIT, DRILL

Public Device Record Key

b5918c06-32ab-4d3f-9ed6-96f69da672a0

Public Version Date

November 22, 2018

Public Version Number

5

DI Record Publish Date

July 08, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-