Thermo Scientific - Fresco 17 120V/60H - Thermo Electron LED GmbH

Duns Number:537396330

Device Description: Fresco 17 120V/60H

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More Product Details

Catalog Number

75002402

Brand Name

Thermo Scientific

Version/Model Number

Fresco 17

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

JQC

Product Code Name

Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use

Device Record Status

Public Device Record Key

7d5b82fc-3cc9-4de3-af06-c76263b85334

Public Version Date

July 19, 2022

Public Version Number

1

DI Record Publish Date

July 11, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"THERMO ELECTRON LED GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 156
2 A medical device with a moderate to high risk that requires special controls. 3