Catalog Number

AMS8616

Brand Name

Aligned Medical Solutions

Version/Model Number

AMS8616

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

OJG

Product Code Name

Neurological tray

Public Device Record Key

29999939-e2ce-4cb2-aed1-a2e0737a9f7a

Public Version Date

December 17, 2018

Public Version Number

1

DI Record Publish Date

November 14, 2018

Package DI Number

B098AMS86161

Quantity per Package

20

Contains DI Package

B098AMS86160

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case