ATLAS Review for i. Profiler plus - N/A - Carl Zeiss Vision GmbH

Duns Number:333928146

Device Description: N/A

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More Product Details

Catalog Number

000000-2360-422

Brand Name

ATLAS Review for i. Profiler plus

Version/Model Number

000000-2360-422

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)

-

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

OUG

Product Code Name

Medical device data system

Device Record Status

Public Device Record Key

4617a423-0f70-4e88-bae1-5c69bc40abc7

Public Version Date

January 11, 2021

Public Version Number

1

DI Record Publish Date

January 01, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CARL ZEISS VISION GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 14