Swing-out rotor

Basic Information

• Brand Name: Swing-out rotor
• Primary DI: 04050674030304
• Version / Model: 8-place
• Catalog Number: 1648
• Company Name: Andreas Hettich GmbH & Co. KG
• Labeler DUNS: 316403245
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-09-02
• Public Version: 1
• Public Version Date: 2021-09-10
• Public Version Status: New
• Public Device Record Key: 7bd581e1-84e9-427c-8cc5-e517b2d4d44b

Device Description

Centrifuge rotor adjustable angle, 8-place

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	862.2050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37531	Centrifuge rotor, adjustable angle	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04050674030304	GS1