Catalog Number

NA-EP10-2040

Brand Name

Expert

Version/Model Number

EP10-2040

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

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

K970574,K970574

Product Code

MQX

Product Code Name

Needle, Acupuncture, Single Use

Public Device Record Key

51320689-0ca7-472d-831d-ee4bdc63c1ca

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 03, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-