Catalog Number

-

Brand Name

NEEDLES 25x1

Version/Model Number

11-251

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

K193526,K193526

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

a6c3f61b-db35-4e50-9541-0decce704a0a

Public Version Date

January 11, 2021

Public Version Number

1

DI Record Publish Date

January 01, 2021

Package DI Number

00369771001853

Quantity per Package

100

Contains DI Package

00369771001846

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner