Catalog Number

NS255A3

Brand Name

Endure

Version/Model Number

NS255A3-0820

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"

Yes

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

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

96471631-a333-46d4-aa3f-f4b940737f05

Public Version Date

April 14, 2021

Public Version Number

1

DI Record Publish Date

April 06, 2021

Package DI Number

00840118604406

Quantity per Package

100

Contains DI Package

00840118604390

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box