Catalog Number

-

Brand Name

EACU, EAKU, ZAGU, JOCU

Version/Model Number

P2015

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K150903,K150903,K150903

Product Code

MQX

Product Code Name

Needle, Acupuncture, Single Use

Public Device Record Key

92a7d1fa-7fbc-4882-b9f3-ce32bc7bebab

Public Version Date

July 19, 2018

Public Version Number

3

DI Record Publish Date

September 22, 2016

Package DI Number

B338P20152

Quantity per Package

10

Contains DI Package

B338P20151

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

bigger box