Catalog Number

AMS6438

Brand Name

Aligned Medical Solutions

Version/Model Number

AMS6438

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

OHD

Product Code Name

Gynecological laparoscopic kit

Public Device Record Key

059b6f42-e944-4f4e-8c9f-4d5451aa60c4

Public Version Date

December 03, 2018

Public Version Number

1

DI Record Publish Date

November 01, 2018

Package DI Number

B098AMS64381

Quantity per Package

20

Contains DI Package

B098AMS64380

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case