FDA.reportPublic FDA data

Clarapath™ SectionStar™

Primary DI
00860012688944
Brand
Clarapath™ SectionStar™
Company
Clarapath, Inc.
Model
810-00001
Device description
Automated tissue sectioning and transfer system
Published
2024-10-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IDOMicrotome, Rotary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IDOMicrotome, RotaryPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198168976302PreviousGS10
00860012688944PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198168976302001981689763021981689763020198168976302
00860012688944008600126889448600126889440860012688944

GMDN Terms#

Term, Definition table
TermDefinition
Rotary microtome IVDA precision cutting instrument intended to be used to cut tissue sections, fixed in paraffin wax, into thin slices for subsequent in vitro diagnostic analysis. The device has a vertically-fixed knife which cuts through the paraffin block vertically, and a flywheel mechanism which cuts sections with each turn.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079469240
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
00860012688968Clarapath™ SectionStar™810-000022025-02-04
00198168976302SectionStar810-000012024-08-16
00860012688906ClaraTape™ Transfer Tape900-000202024-08-23
10860012688903ClaraTape™ Transfer Tape900-000202024-08-23
00860012688913ClaraCut™ Blades900-000222024-08-23
00860012688920ClaraBond™ Slide Coater Adhesive900-000212024-08-23
00860012688937ClaraMount™ Coverslip mounting medium900-000232024-08-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05051663010580EprediaSHANDON DIAGNOSTICS LIMITEDIDO2025-06-11
00860012688968Clarapath™ SectionStar™Clarapath, Inc.IDO2025-02-04
00198168976302SectionStarClarapath, Inc.IDO2024-08-16
05051663010528EprediaSHANDON DIAGNOSTICS LIMITEDIDO2024-05-10
05051663010559EprediaSHANDON DIAGNOSTICS LIMITEDIDO2024-05-10
05051663517898EprediaSHANDON DIAGNOSTICS LIMITEDIDO2024-02-14
05051663517904EprediaSHANDON DIAGNOSTICS LIMITEDIDO2024-02-14
05051663517911EprediaSHANDON DIAGNOSTICS LIMITEDIDO2024-02-14
05051663005142EprediaSHANDON DIAGNOSTICS LIMITEDIDO2023-07-28
05051663005166EprediaSHANDON DIAGNOSTICS LIMITEDIDO2023-07-28
05051663005180EprediaSHANDON DIAGNOSTICS LIMITEDIDO2023-07-28
05051663005203EprediaSHANDON DIAGNOSTICS LIMITEDIDO2023-07-28
05051663005227EprediaSHANDON DIAGNOSTICS LIMITEDIDO2023-07-28
05051663005241EprediaSHANDON DIAGNOSTICS LIMITEDIDO2023-07-28
05051663005258EprediaSHANDON DIAGNOSTICS LIMITEDIDO2023-07-28
06971182570978MT1 Rotary MicrotomeDakewe (Shenzhen) Medical Equipment Co., Ltd.IDO2022-06-07
05051663010443EprediaSHANDON DIAGNOSTICS LIMITEDIDO2021-02-14
05051663005128EprediaSHANDON DIAGNOSTICS LIMITEDIDO2021-02-10
05051663010078EprediaSHANDON DIAGNOSTICS LIMITEDIDO2021-02-10
05051663010085EprediaSHANDON DIAGNOSTICS LIMITEDIDO2021-02-10
05051663010092EprediaSHANDON DIAGNOSTICS LIMITEDIDO2021-02-10
05051663010108EprediaSHANDON DIAGNOSTICS LIMITEDIDO2021-02-10
05051663010115EprediaSHANDON DIAGNOSTICS LIMITEDIDO2021-02-10
08720177655170Accu-Cut® SRM™ 200SAKURA FINETEK U.S.A., INC.IDO2020-08-21
06971182570084LS-2065 Rotary MicrotomeDakewe (Shenzhen) Medical Equipment Co., Ltd.IDO2020-08-01
069711825701452065A Auto MicrotomeDakewe (Shenzhen) Medical Equipment Co., Ltd.IDO2020-08-01
00615233012937Accu-Cut® SRM™ 200SAKURA FINETEK U.S.A., INC.IDO2020-03-31
00615233012944Accu-Cut® SRM™ 200SAKURA FINETEK U.S.A., INC.IDO2020-03-31
00615233008213Accu-Cut® SRM™ 300 LTSAKURA FINETEK U.S.A., INC.IDO2020-02-06
00615233008220Accu-Cut® SRM™ 300 LTSAKURA FINETEK U.S.A., INC.IDO2020-02-06