Catalog Number

MPE1002MS-Kit

Brand Name

Eclipse MicroPen Elite Turbo Safety Cartridge

Version/Model Number

MPE1002MS-Kit

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 31, 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)

-

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

3c290d52-69da-4b5a-a108-88b2b99406a2

Public Version Date

November 06, 2020

Public Version Number

3

DI Record Publish Date

May 03, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-