FDA.report

Angle rotor

Primary DI
04050674028400
Brand
Angle rotor
Company
Andreas Hettich GmbH & Co. KG
Model
6-place
Catalog number
4794
Device description
Centrifuge rotor fixed angle, 6-place
Published
2021-09-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical Use

Product Code Classifications

CodeDeviceSpecialtyClass
JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical UseClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04050674028400PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04050674028400040506740284004050674028400

GMDN Terms

TermDefinition
Centrifuge rotor, fixed angleA device, commonly called the rotor, or rotor head, used as a component in a centrifuge. It is designed with the tube holding bores formed at a pre-set angle and pattern. It is horizontally attached at the top of the vertical shaft which is part of the electrically-powered drive unit and the samples to be centrifuged are placed in this rotor.

Sterilization Methods

Method

Regulatory Flags

DUNS number
316403245
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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