Tissue-Tek® TEC™ 6 - Embedding Console System - SAKURA FINETEK U.S.A., INC.

Duns Number:179135769

Device Description: Embedding Console System

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More Product Details

Catalog Number

5110

Brand Name

Tissue-Tek® TEC™ 6

Version/Model Number

5110

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

IDW

Product Code Name

DISPENSERS, PARAFFIN

Device Record Status

Public Device Record Key

48288b44-07dc-4780-9d00-1072bda2e812

Public Version Date

December 04, 2020

Public Version Number

2

DI Record Publish Date

August 03, 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