FDA.reportPublic FDA data

Thermo Scientific

Primary DI
10850685007323
Brand
Thermo Scientific
Company
Thermo Electron LED GmbH
Model
Sorvall Legend XTR
Catalog number
75004521
Device description
Sorvall Legend XTR 120V 60Hz
Published
2018-09-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KSOCentrifuge, Blood-Bank For In Vitro Diagnostic Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSOCentrifuge, Blood-Bank For In Vitro Diagnostic UseHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850685007323PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085068500732310850685007323

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose centrifuge IVDAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+496184906000marilyn.barry@thermofisher.com

Regulatory Flags#

DUNS number
537396330
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850044310262Thermo ScientificThermo Scientific MT 17 IVD-MD750025772026-05-21
10850044310279Thermo ScientificThermo Scientific MT 17 IVD-MD750025782026-05-21
10850044310309Thermo ScientificThermo Scientific MT 21 IVD-MD750025802026-05-21
10850044310323Fisher ScientificFisherbrand accuSpin 17-HC750025282026-04-22
10850044310347Fisher ScientificFisherbrand accuSpin 17R-HC750025292026-04-22
10850044310354Fisher ScientificFisherbrand accuSpin 21-HC750025302026-04-22
10850044310422Fisher ScientificFisherbrand accuSpin 21R-HC750025312026-04-22
10850044310224Thermo ScientificThermo Scientific S4T IVD-MD750073322026-04-02
10850044310248Thermo ScientificThermo Scientific X4T IVD-MD750073412026-04-02
10850044310255Thermo ScientificThermo Scientific MT 17 IVD-MD750025762026-03-10
10850044310286Thermo ScientificThermo Scientific MT 17 IVD-MD750025982026-03-10
10850044310293Thermo ScientificThermo Scientific MT 21 IVD-MD750025792026-03-10
10850044310378Thermo ScientificThermo Scientific MTR 17 IVD-MD750025882026-03-10
10850044310392Thermo ScientificThermo Scientific MTR 21 IVD-MD750025912026-03-10
10850044310484Thermo ScientificThermo Scientific MTR 21 IVD-MD750025992026-03-10
10850044310491Thermo ScientificThermo Scientific MTR 17 IVD-MD750025972026-03-10
10850044310033Thermo ScientificThermo Scientific C1TR IVD-MD750091022025-12-01
10850044310149Thermo ScientificThermo Scientific C1FR IVD-MD750091202025-12-01
10850044310170Thermo ScientificThermo Scientific C1T IVD-MD750080042025-12-01
10850044310187Thermo ScientificThermo Scientific C1T IVD-MD750080052025-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850033408888Thermo ScientificThermo Electron LED GmbHKSO2025-01-27
10850033408918Thermo ScientificThermo Electron LED GmbHKSO2025-01-27
10850033408932Thermo ScientificThermo Electron LED GmbHKSO2025-01-27
10850033408963Thermo ScientificThermo Electron LED GmbHKSO2025-01-27
10850033408987Thermo ScientificThermo Electron LED GmbHKSO2025-01-27
10850685007408Thermo ScientificThermo Electron LED GmbHKSO2022-10-04
10850685007415Thermo ScientificThermo Electron LED GmbHKSO2022-10-04
10850685007422Thermo ScientificThermo Electron LED GmbHKSO2022-10-04
10850685007439Thermo ScientificThermo Electron LED GmbHKSO2022-10-04
10850685007446Thermo ScientificThermo Electron LED GmbHKSO2022-10-04
10850685007453Thermo ScientificThermo Electron LED GmbHKSO2022-10-04
04050674026055BucketAndreas Hettich GmbHKSO2021-09-03
04050674026062BucketAndreas Hettich GmbHKSO2021-09-03
04050674026093BucketAndreas Hettich GmbHKSO2021-09-03
04050674026116BucketAndreas Hettich GmbHKSO2021-09-03
04050674026147BucketAndreas Hettich GmbHKSO2021-09-03
04050674026550BucketAndreas Hettich GmbHKSO2021-09-03
04050674026840BucketAndreas Hettich GmbHKSO2021-09-03
04050674052559BucketAndreas Hettich GmbHKSO2021-09-03
04050674052580BucketAndreas Hettich GmbHKSO2021-09-03
04050674052917BucketAndreas Hettich GmbHKSO2021-09-03
04050674054546BucketAndreas Hettich GmbHKSO2021-09-03
04050674061315BucketAndreas Hettich GmbHKSO2021-09-03
04050674061322BucketAndreas Hettich GmbHKSO2021-09-03
04050674061339BucketAndreas Hettich GmbHKSO2021-09-03
04050674061421BucketAndreas Hettich GmbHKSO2021-09-03
04050674065597BucketAndreas Hettich GmbHKSO2021-09-03
04050674067713BucketAndreas Hettich GmbHKSO2021-09-03
04050674068635BucketAndreas Hettich GmbHKSO2021-09-03
04050674069052BucketAndreas Hettich GmbHKSO2021-09-03