ZEISS Axio Lab - Carl Zeiss Suzhou Co., Ltd.

Duns Number:528182577

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More Product Details

Catalog Number

430037-9000-000

Brand Name

ZEISS Axio Lab

Version/Model Number

Axio Lab.A1

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

MTX

Product Code Name

Microscope and microscope accessories, reproduction, assisted

Device Record Status

Public Device Record Key

6998ba12-4601-48c9-b7f9-fed4c35cfe16

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 SUZHOU CO., LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 21
2 A medical device with a moderate to high risk that requires special controls. 1