Tissue-Tek Xpress® - Processing Reagent Set, Formula 1 - SAKURA FINETEK U.S.A., INC.

Duns Number:179135769

Device Description: Processing Reagent Set, Formula 1

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More Product Details

Catalog Number

7110

Brand Name

Tissue-Tek Xpress®

Version/Model Number

7110

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

PPM

Product Code Name

General purpose reagent

Device Record Status

Public Device Record Key

6f22caec-4d1c-4185-bb90-4a7f0ecd9f0b

Public Version Date

December 23, 2019

Public Version Number

1

DI Record Publish Date

December 15, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SAKURA FINETEK U.S.A., INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 733