Catalog Number

-

Brand Name

IDryNeedle 0.45x105

Version/Model Number

DN161 0.45x105

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

3625f3e4-c1a9-491c-b8bd-61e9af00b630

Public Version Date

July 27, 2020

Public Version Number

1

DI Record Publish Date

July 17, 2020

Package DI Number

28809407787660

Quantity per Package

10000

Contains DI Package

18809407787663

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON BOX