AccessGUDID - DEVICE: Swing-out rotor (04050674029988)

GUDID

Device Identifier (DI) Information

Brand Name: Swing-out rotor
Version or Model: 8-place
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1611
Company Name: Andreas Hettich GmbH & Co. KG

Primary DI Number: 04050674029988
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316403245 *Terms of Use

Device Description: Centrifuge rotor adjustable angle, 8-place

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 49bb11d5-5c13-4c04-8bb9-265bf42a098c
Public Version Date: September 10, 2021
Public Version Number: 1
DI Record Publish Date: September 02, 2021