Thermo Scientific TSX Series High-Performance Plasma Freezer - Thermo Scientific TSX Series High-Performance - KEY SCIENTIFIC INC

Duns Number:938286804

Device Description: Thermo Scientific TSX Series High-Performance Plasma Freezer

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More Product Details

Catalog Number

TSX1230LY

Brand Name

Thermo Scientific TSX Series High-Performance Plasma Freezer

Version/Model Number

TSX1230LY

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

KSE

Product Code Name

Refrigerator, Freezer, Blood Storage

Device Record Status

Public Device Record Key

9b7c701f-ea91-46f3-9d49-d95db327bc15

Public Version Date

January 19, 2022

Public Version Number

1

DI Record Publish Date

January 11, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KEY SCIENTIFIC INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 255