Catalog Number

DDS1138

Brand Name

Aligned Medical Solutions

Version/Model Number

DDS1138

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

OHG

Product Code Name

Circumcision tray

Public Device Record Key

f69ddf3d-309a-4a48-b595-2161a2e99496

Public Version Date

December 17, 2018

Public Version Number

1

DI Record Publish Date

November 14, 2018

Package DI Number

B098DDS11381

Quantity per Package

20

Contains DI Package

B098DDS11380

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case