Catalog Number

A000685

Brand Name

S NEEDLE

Version/Model Number

J-Type 2040 Place N' Press

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

K031716,K031716,K031716,K031716

Product Code

MQX

Product Code Name

Needle, Acupuncture, Single Use

Public Device Record Key

d9e6205b-f5de-4ba4-acc3-6a905c23f346

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 30, 2017

Package DI Number

04251282512231

Quantity per Package

10

Contains DI Package

04251282512224

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

parcel