Catalog Number

-

Brand Name

AHS

Version/Model Number

AHS2125RN

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

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

108a3a1f-4130-43e7-b2ee-7c279a799c62

Public Version Date

November 09, 2020

Public Version Number

6

DI Record Publish Date

March 31, 2016

Package DI Number

B031AHS2125RN2

Quantity per Package

10000

Contains DI Package

B031AHS2125RN1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton