FDA.reportPublic FDA data

LS-2065 Rotary Microtome

Primary DI
06971182570084
Brand
LS-2065 Rotary Microtome
Company
Dakewe (Shenzhen) Medical Equipment Co., Ltd.
Model
LS-2065
Published
2020-08-01
Public version status
Update
Distribution status
Not 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
06971182570084PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971182570084069711825700846971182570084

GMDN Terms#

Term, Definition table
TermDefinition
Rotary microtomeA microtome designed for cutting sections of tissue samples into thin slices. The sample is usually secured (fixed) in paraffin wax prior to cutting. The sections are cut by each turn of its flywheel.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
554456618
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
069711825701452065A Auto Microtome2065A2020-08-01
06971182571005Adhesion Microscope SlidesDKWAS001A2024-12-27
06971182571159Microscope Slides7109030A2024-12-27
06971182571166Embedding CassetteC002024-12-27
06971182571173Embedding CassetteC012024-12-27
06971182571180Embedding CassetteC022024-12-27
06971182571197Embedding CassetteC032024-12-27
06971182571241Microscope Cover Glass030.009.011-002024-12-27
06971182571258CT520 Cryostat MicrotomeCT5202024-12-27
06971182571265Microscope Slides7109040A2024-12-27
06971182571326Fully Automated IHC StainerNS402024-12-27
06971182570947HP300Plus Automatic Tissue ProcessorHP300Plus2022-06-06
06971182570046HP300 Automatic Tissue ProcessorHP3002020-08-01
06971182570978MT1 Rotary MicrotomeMT12022-06-07
06971182570015DP260 slide stainerDP2602020-08-01
06971182570183DP360 slide stainerDP3602020-08-01
06971182570190CS500 Glass CoverslipperCS5002020-08-01
069711825702066250 Cryostat Microtome62502020-08-01

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
00860012688944Clarapath™ SectionStar™Clarapath, Inc.IDO2024-10-22
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
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