Catalog Number

TD500/A

Brand Name

SeaDragon2™

Version/Model Number

00884450458068

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DQX

Product Code Name

Wire, guide, catheter

Public Device Record Key

0adb35f0-1d7b-4552-b9f1-c36de2a15ddc

Public Version Date

August 24, 2020

Public Version Number

1

DI Record Publish Date

August 14, 2020

Package DI Number

10884450458065

Quantity per Package

10

Contains DI Package

00884450458068

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-