Catalog Number

311.44.EM

Brand Name

EMERGE MEDICAL & Design

Version/Model Number

311.44.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

HWX

Product Code Name

TAP, BONE

Public Device Record Key

5b5e8d09-3133-4e50-8b06-e0e91372dcb1

Public Version Date

August 09, 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

-