Catalog Number

00788611

Brand Name

Aligned Medical Solutions

Version/Model Number

00788611

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)

-

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

b2914528-e53f-43a9-a018-0a6b618c81ab

Public Version Date

December 03, 2018

Public Version Number

1

DI Record Publish Date

October 31, 2018

Package DI Number

B098007886111

Quantity per Package

4

Contains DI Package

B098007886110

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case