Catalog Number

-

Brand Name

M&S Technologies Smart System® 20/20

Version/Model Number

Smart System 20/20

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

-

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

HOS

Product Code Name

Projector, Ophthalmic

Public Device Record Key

ebc48eb7-9c0b-45dd-8b02-0f23245edb3c

Public Version Date

September 19, 2022

Public Version Number

2

DI Record Publish Date

July 06, 2022

Package DI Number

00850040295047

Quantity per Package

1

Contains DI Package

00850040295566

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

SS-2020-USA