Catalog Number

224.64.EM

Brand Name

EMERGE MEDICAL & Design

Version/Model Number

224.64.EM

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 16, 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

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

-

Product Code

HRS

Product Code Name

PLATE, FIXATION, BONE

Public Device Record Key

f590152b-ac32-4bdd-ab3e-e15ce4fc3b1b

Public Version Date

July 17, 2018

Public Version Number

4

DI Record Publish Date

July 07, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-