Catalog Number

AMS4449A

Brand Name

Aligned Medical Solutions

Version/Model Number

AMS4449A

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

OHM

Product Code Name

Cesarean section tray

Public Device Record Key

58fedf31-9be0-4b2a-93ec-434fca7f68f5

Public Version Date

April 16, 2019

Public Version Number

1

DI Record Publish Date

April 08, 2019

Package DI Number

B098AMS4449A1

Quantity per Package

4

Contains DI Package

B098AMS4449A0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case