Catalog Number

-

Brand Name

EACU, EAKU, ZAGU, JOCU

Version/Model Number

SIX2030

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

84aa3f67-881c-4ef8-b156-c18e48289574

Public Version Date

April 02, 2019

Public Version Number

1

DI Record Publish Date

March 25, 2019

Package DI Number

B338SIX20302

Quantity per Package

10

Contains DI Package

B338SIX20301

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

bigger box