Angle rotor - Centrifuge rotor fixed angle, 18-place - Andreas Hettich GmbH & Co. KG

Duns Number:316403245

Device Description: Centrifuge rotor fixed angle, 18-place

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More Product Details

Catalog Number

1258-A

Brand Name

Angle rotor

Version/Model Number

18-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

JQC

Product Code Name

Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use

Device Record Status

Public Device Record Key

b3db8e17-49f6-40bc-aa02-2c4b5b87f03c

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