Catalog Number

-

Brand Name

SUMMIT MEDICAL

Version/Model Number

AFTD-Y

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 09, 2021

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

BYY

Product Code Name

Tube, Aspirating, Flexible, Connecting

Public Device Record Key

9b91c24e-666f-4fe4-8007-741fa2cab346

Public Version Date

August 23, 2021

Public Version Number

3

DI Record Publish Date

April 20, 2021

Package DI Number

10385640052037

Quantity per Package

1

Contains DI Package

00385640052030

Package Discontinue Date

August 09, 2021

Package Status

Not in Commercial Distribution

Package Type

Box