Catalog Number

-

Brand Name

SUMMIT MEDICAL

Version/Model Number

AFTD-Y

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

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

KGZ

Product Code Name

Accessories, Catheter

Public Device Record Key

ae32440c-dcad-4f2f-8733-b4dc9524a99e

Public Version Date

July 27, 2022

Public Version Number

4

DI Record Publish Date

April 26, 2021

Package DI Number

10385640064924

Quantity per Package

10

Contains DI Package

00385640064927

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX