FDA.reportPublic FDA data

6250 Cryostat Microtome

Primary DI
06971182570206
Brand
6250 Cryostat Microtome
Company
Dakewe (Shenzhen) Medical Equipment Co., Ltd.
Model
6250
Published
2020-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IDPMicrotome, Cryostat

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IDPMicrotome, CryostatPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971182570206PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971182570206069711825702066971182570206

GMDN Terms#

Term, Definition table
TermDefinition
Cryostat microtomeAn instrument that consists of a microtome contained in a temperature-controlled cabinet called a cryostat. The cryostat microtome allows the operator to section frozen tissue specimens without lengthy fixation procedures, thereby speeding diagnosis.

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
06971182570084LS-2065 Rotary MicrotomeLS-20652020-08-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05051663011501EprediaSHANDON DIAGNOSTICS LIMITEDIDP2025-11-07
05051663011518EprediaSHANDON DIAGNOSTICS LIMITEDIDP2025-11-07
05051663011112EprediaSHANDON DIAGNOSTICS LIMITEDIDP2025-08-26
05051663011129EprediaSHANDON DIAGNOSTICS LIMITEDIDP2025-08-26
06971182571258CT520 Cryostat MicrotomeDakewe (Shenzhen) Medical Equipment Co., Ltd.IDP2024-12-27
05051663003520EprediaSHANDON DIAGNOSTICS LIMITEDIDP2024-02-15
05051663003537EprediaSHANDON DIAGNOSTICS LIMITEDIDP2024-02-15
05051663003544EprediaSHANDON DIAGNOSTICS LIMITEDIDP2024-02-15
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05051663003629EprediaSHANDON DIAGNOSTICS LIMITEDIDP2024-02-15
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05051663003872EprediaSHANDON DIAGNOSTICS LIMITEDIDP2024-02-15
05051663003889EprediaSHANDON DIAGNOSTICS LIMITEDIDP2023-08-09
05051663003896EprediaSHANDON DIAGNOSTICS LIMITEDIDP2023-08-09
05051663005432EprediaSHANDON DIAGNOSTICS LIMITEDIDP2023-08-09
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05051663003483EprediaSHANDON DIAGNOSTICS LIMITEDIDP2023-07-26
05051663003490EprediaSHANDON DIAGNOSTICS LIMITEDIDP2023-07-26
05051663003506EprediaSHANDON DIAGNOSTICS LIMITEDIDP2023-07-26
05051663003513EprediaSHANDON DIAGNOSTICS LIMITEDIDP2023-07-26
05051663003568EprediaSHANDON DIAGNOSTICS LIMITEDIDP2023-07-26
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05051663003612EprediaSHANDON DIAGNOSTICS LIMITEDIDP2023-07-26
05051663003636EprediaSHANDON DIAGNOSTICS LIMITEDIDP2023-07-26
05051663003643EprediaSHANDON DIAGNOSTICS LIMITEDIDP2023-07-26