Catalog Number

-

Brand Name

Press Needles by Energy Flo

Version/Model Number

CRS 0.20 x 1.0mm Box of 100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code

MQX

Product Code Name

Needle, Acupuncture, Single Use

Public Device Record Key

09254d46-3e9e-4a94-990d-fbc01c03baf2

Public Version Date

May 31, 2019

Public Version Number

1

DI Record Publish Date

May 23, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-