FDA.report

Swing-out rotor

Primary DI
04050674074339
Brand
Swing-out rotor
Company
Andreas Hettich GmbH & Co. KG
Model
2-place
Catalog number
5622
Device description
Centrifuge rotor adjustable angle, 2-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
KSOCentrifuge, Blood-Bank For In Vitro Diagnostic Use

Product Code Classifications

CodeDeviceSpecialtyClass
KSOCentrifuge, Blood-Bank For In Vitro Diagnostic UseHematology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04050674074339PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04050674074339040506740743394050674074339

GMDN Terms

TermDefinition
Centrifuge rotor, adjustable angleA device, commonly called the rotor, or rotor head, used as a component in a centrifuge. It is designed with the tube holding devices shaped like buckets which are self adjusting. These swing outwardly at an increasing angle from the vertical still position in relationship to the centrifugal force. 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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