Catalog Number

MP1002-II-K12HA

Brand Name

Eclipse MicroPen Elite

Version/Model Number

MP1002-II-K12HA

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 03, 2019

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

-

Product Code Name

-

Public Device Record Key

fbdac053-14ea-4f8f-aa79-7714636b8c3a

Public Version Date

July 07, 2020

Public Version Number

3

DI Record Publish Date

October 04, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-