Catalog Number

50EVO1000-010

Brand Name

Eclipse MicroPen EVO

Version/Model Number

50EVO1000-010

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K203144,K212558,K203144,K212558,K203144,K212558

Product Code

QAI

Product Code Name

Powered Microneedle Device

Public Device Record Key

0fb2429e-d0da-40c6-983e-8b52f86abdad

Public Version Date

January 19, 2022

Public Version Number

1

DI Record Publish Date

January 11, 2022

Package DI Number

00853602008673

Quantity per Package

1

Contains DI Package

00853602008598

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Kit