MIRROR CHART MC-5S for COMPU VISION CV-5000 - TOPCON CORPORATION

Duns Number:690542881

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

MIRROR CHART MC-5S for COMPU VISION CV-5000

Version/Model Number

MC-5S

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

HOX

Product Code Name

Chart, Visual Acuity

Device Record Status

Public Device Record Key

a5877e93-a32b-4cda-8466-04d9f1eb0e78

Public Version Date

July 01, 2022

Public Version Number

1

DI Record Publish Date

June 23, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TOPCON CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 19
2 A medical device with a moderate to high risk that requires special controls. 64