Catalog Number

-

Brand Name

KM NEEDLE

Version/Model Number

KMS BE03015201

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

-

Product Code

MQX

Product Code Name

Needle, Acupuncture, Single Use

Public Device Record Key

e9c5f58b-fc02-4d2a-b4db-40610c63956c

Public Version Date

July 29, 2019

Public Version Number

1

DI Record Publish Date

July 21, 2019

Package DI Number

38800020500619

Quantity per Package

10000

Contains DI Package

28800020500612

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-