Catalog Number

-

Brand Name

M&S Technologies ACUITYex

Version/Model Number

EX-100

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

52371e9d-42d0-46f7-a5b4-a08061f3e656

Public Version Date

July 14, 2022

Public Version Number

1

DI Record Publish Date

July 06, 2022

Package DI Number

00850040295351

Quantity per Package

1

Contains DI Package

00850040295238

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

EX-PC-SFT