AccessGUDID - DEVICE: Thermo Scientific (10850685007361)

GUDID

Device Identifier (DI) Information

Brand Name: Thermo Scientific
Version or Model: Sorvall ST 40
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 75004509
Company Name: Thermo Electron LED GmbH

Primary DI Number: 10850685007361
Issuing Agency: GS1
Commercial Distribution End Date: November 28, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 537396330 *Terms of Use

Device Description: Sorvall ST 40 230V 50/60Hz

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):	No
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?
36465	General-purpose centrifuge IVD	An electrically-powered device intended to be used to separate the components of multiple types and various volumes of clinical suspensions using centrifugal force. It is a self-contained unit with an electric motor, a vertical shaft, and a horizontal rotor attached to the upper end. It is typically used to centrifuge various types of clinical specimens, either alone or after addition of reagents or other additives, for subsequent in vitro diagnostic analysis. It may additionally have refrigeration capabilities to perform temperature-sensitive procedures.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KSO	Centrifuge, Blood-Bank For In Vitro Diagnostic 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: b4850943-2be2-4996-af32-3af095b544e1
Public Version Date: June 21, 2023
Public Version Number: 3
DI Record Publish Date: September 26, 2018