Catalog Number

-

Brand Name

Haeng Lim Acupuncture Needles

Version/Model Number

HL-00125105C

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K092240

Product Code

MQX

Product Code Name

Needle, Acupuncture, Single Use

Public Device Record Key

5a2485bc-afd3-4f20-bd13-b2c7f0198bc1

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

March 26, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-