Catalog Number

-

Brand Name

AMG

Version/Model Number

6011

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

K193526,K193526,K193526

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

6464d89b-c5c1-4766-b01e-b57536a08bf5

Public Version Date

June 14, 2021

Public Version Number

2

DI Record Publish Date

March 09, 2021

Package DI Number

10810069260379

Quantity per Package

100

Contains DI Package

00810069260372

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box