Catalog Number

-

Brand Name

KSC DB Plus

Version/Model Number

DB-3060G

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)

Yes

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

dce09b0c-7549-43f5-8371-a0b662453537

Public Version Date

November 25, 2020

Public Version Number

3

DI Record Publish Date

August 26, 2016

Package DI Number

06953717720492

Quantity per Package

10

Contains DI Package

06953717710493

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case