Catalog Number

-

Brand Name

Regard

Version/Model Number

HT0870

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 26, 2019

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

OES

Product Code Name

Cardiac Catheterization Kit

Public Device Record Key

abc4cd04-0776-4d55-8307-8f746ed00d48

Public Version Date

September 27, 2019

Public Version Number

3

DI Record Publish Date

September 06, 2017

Package DI Number

20326053113226

Quantity per Package

3

Contains DI Package

10326053113229

Package Discontinue Date

September 26, 2019

Package Status

Not in Commercial Distribution

Package Type

-