Catalog Number

AN3800

Brand Name

Autopen

Version/Model Number

AN3800

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K983974,K983974

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

151f7488-bb6c-4820-80ef-5286cc17c256

Public Version Date

July 01, 2021

Public Version Number

4

DI Record Publish Date

September 19, 2016

Package DI Number

00384703800038

Quantity per Package

100

Contains DI Package

00384703800014

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case