Catalog Number

-

Brand Name

Huber Needle Extension Set

Version/Model Number

TID - H

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

K982047

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

687ae593-f598-4299-a840-d5c765c9cff8

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

December 30, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-