Catalog Number

PSS2457B

Brand Name

Aligned Medical Solutions

Version/Model Number

PSS2457B

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

d51f596f-73c1-445f-b8f7-a12fbd185603

Public Version Date

May 07, 2019

Public Version Number

2

DI Record Publish Date

November 14, 2018

Package DI Number

B098PSS2457B1

Quantity per Package

8

Contains DI Package

B098PSS2457B0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case