Swing-out rotor - Centrifuge rotor adjustable angle, 24-place - Andreas Hettich GmbH & Co. KG

Duns Number:316403245

Device Description: Centrifuge rotor adjustable angle, 24-place

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More Product Details

Catalog Number

1154-L

Brand Name

Swing-out rotor

Version/Model Number

24-place

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

GKG

Product Code Name

Centrifuge, Hematocrit

Device Record Status

Public Device Record Key

6ab6d469-9a3d-4fd6-9605-5a3a9e68a3ac

Public Version Date

September 10, 2021

Public Version Number

1

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