Catalog Number

AMS4933

Brand Name

Aligned Medical Solutions

Version/Model Number

AMS4933

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

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

OEZ

Product Code Name

Cardiovascular procedure kit

Public Device Record Key

e2d6e7df-dce5-4061-90ef-c642d0a9defa

Public Version Date

December 03, 2018

Public Version Number

1

DI Record Publish Date

November 01, 2018

Package DI Number

B098AMS49331

Quantity per Package

1

Contains DI Package

B098AMS49330

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case