Tissue-Tek® - 10% Neutral Buffered Formalin - SAKURA FINETEK U.S.A., INC.

Duns Number:179135769

Device Description: 10% Neutral Buffered Formalin

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More Product Details

Catalog Number

5993

Brand Name

Tissue-Tek®

Version/Model Number

5993

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

dcc12fee-177b-4a93-a9fb-0c1d5a0bc2be

Public Version Date

September 14, 2020

Public Version Number

1

DI Record Publish Date

September 05, 2020

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