EBA 200S - Tabletop centrifuge - Andreas Hettich GmbH & Co. KG

Duns Number:316403245

Device Description: Tabletop centrifuge

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More Product Details

Catalog Number

1802-01

Brand Name

EBA 200S

Version/Model Number

EBA 200S - 100V-127V/50-60Hz

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)

Yes

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

14b1dfd3-f9c3-4c7f-9037-a6b07e7cafd6

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

September 02, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ANDREAS HETTICH GMBH & CO. KG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 201
2 A medical device with a moderate to high risk that requires special controls. 38