Catalog Number

AMS3163B

Brand Name

Aligned Medical Solutions

Version/Model Number

AMS3163B

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

Yes

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

-

FDA Premarket Submission

-

Product Code

OGE

Product Code Name

Epidural anesthesia kit

Public Device Record Key

4b213276-8ab8-4068-bcba-313d1c501a5c

Public Version Date

July 22, 2019

Public Version Number

2

DI Record Publish Date

November 01, 2018

Package DI Number

B098AMS3163B1

Quantity per Package

20

Contains DI Package

B098AMS3163B0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case