Catalog Number

-

Brand Name

Hansol Medical Co.

Version/Model Number

0.35mm x 15mm

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

K090910,K090910

Product Code

MQX

Product Code Name

Needle, Acupuncture, Single Use

Public Device Record Key

0eba8bb1-76fa-459d-8109-e8dd39953093

Public Version Date

May 17, 2021

Public Version Number

2

DI Record Publish Date

February 11, 2019

Package DI Number

18809118710578

Quantity per Package

10

Contains DI Package

08809118710571

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton box