Catalog Number

VMIMPACKAA

Brand Name

Aligned Medical Solutions

Version/Model Number

VMIMPACKAA

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

OFX

Product Code Name

General purpose dental tray

Public Device Record Key

fb67b154-a5e0-4f52-a34a-c90f4d6d7e9d

Public Version Date

June 26, 2019

Public Version Number

1

DI Record Publish Date

June 18, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-