Catalog Number

AMS6908B

Brand Name

Aligned Medical Solutions

Version/Model Number

AMS6908B

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

Yes

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

-

FDA Premarket Submission

-

Product Code

OEQ

Product Code Name

Angiography/angioplasty kit

Public Device Record Key

750ae181-c58e-42ed-9097-f34ad83d9fed

Public Version Date

December 28, 2018

Public Version Number

1

DI Record Publish Date

November 27, 2018

Package DI Number

B098AMS6908B1

Quantity per Package

6

Contains DI Package

B098AMS6908B0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case