Catalog Number

-

Brand Name

ACU-NEEDLE

Version/Model Number

N2235

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

K874024,K874024

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

031bb213-85b0-44ce-817e-5512452c22aa

Public Version Date

January 13, 2020

Public Version Number

1

DI Record Publish Date

January 03, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-