Catalog Number

AMS7163

Brand Name

Aligned Medical Solutions

Version/Model Number

AMS7163

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

c0a83dc5-b5ac-4ed5-b580-eed193d5df5c

Public Version Date

December 14, 2018

Public Version Number

1

DI Record Publish Date

November 13, 2018

Package DI Number

B098AMS71631

Quantity per Package

4

Contains DI Package

B098AMS71630

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case