Thermo Scientific - Thermo Scientific TDE Series Ultra-Low - KEY SCIENTIFIC INC

Duns Number:938286804

Device Description: Thermo Scientific TDE Series Ultra-Low Temperature Freezer

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More Product Details

Catalog Number

TDE60086LV

Brand Name

Thermo Scientific

Version/Model Number

TDE60086LV

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

42afef3a-1755-4787-b8f3-4f67500a134c

Public Version Date

April 22, 2019

Public Version Number

1

DI Record Publish Date

April 12, 2019

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