Catalog Number

EMNPAED06USMP

Brand Name

Safety Needle Cartridge 6-MNP 1.5 Exceed US

Version/Model Number

EMNPAED06USMP

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

QAI

Product Code Name

Powered Microneedle Device

Public Device Record Key

ef2ff88f-fdf2-4f75-af63-1a064c691101

Public Version Date

November 29, 2021

Public Version Number

4

DI Record Publish Date

October 23, 2018

Package DI Number

EMTDEMNPAED06USMP1

Quantity per Package

8

Contains DI Package

EMTDEMNPAED06USMP0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box