FDA.reportPublic FDA data

CT620 Cryostat Microtome

Primary DI
06971182571548
Brand
CT620 Cryostat Microtome
Company
Dakewe (Shenzhen) Medical Equipment Co., Ltd.
Model
CT620
Published
2026-07-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
06971182571548PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971182571548069711825715486971182571548

GMDN Terms#

Term, Definition table
TermDefinition
Cryostat microtome IVDA precision cutting instrument contained within a temperature-controlled cabinet (i.e., a cryostat) intended to be used for the sectioning of rapidly-frozen tissue specimens without prior fixation to expedite subsequent in vitro diagnostic analysis of the tissue specimen.

Regulatory Flags#

DUNS number
554456618
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971182571449HP-HUGO Automatic Tissue ProcessorHP-HUGO2026-07-07
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
069711825702066250 Cryostat Microtome62502020-08-01

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
05051663003551EprediaSHANDON DIAGNOSTICS LIMITEDIDP2024-02-15
05051663003582EprediaSHANDON DIAGNOSTICS LIMITEDIDP2024-02-15
05051663003599EprediaSHANDON DIAGNOSTICS LIMITEDIDP2024-02-15
05051663003605EprediaSHANDON DIAGNOSTICS LIMITEDIDP2024-02-15
05051663003629EprediaSHANDON DIAGNOSTICS LIMITEDIDP2024-02-15
05051663003865EprediaSHANDON DIAGNOSTICS LIMITEDIDP2024-02-15
05051663003872EprediaSHANDON DIAGNOSTICS LIMITEDIDP2024-02-15
05051663003889EprediaSHANDON DIAGNOSTICS LIMITEDIDP2023-08-09
05051663003896EprediaSHANDON DIAGNOSTICS LIMITEDIDP2023-08-09
05051663005432EprediaSHANDON DIAGNOSTICS LIMITEDIDP2023-08-09
05051663005456EprediaSHANDON DIAGNOSTICS LIMITEDIDP2023-08-09
05051663003469EprediaSHANDON DIAGNOSTICS LIMITEDIDP2023-07-26
05051663003476EprediaSHANDON DIAGNOSTICS LIMITEDIDP2023-07-26
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
05051663003575EprediaSHANDON DIAGNOSTICS LIMITEDIDP2023-07-26
05051663003612EprediaSHANDON DIAGNOSTICS LIMITEDIDP2023-07-26
05051663003636EprediaSHANDON DIAGNOSTICS LIMITEDIDP2023-07-26
05051663003643EprediaSHANDON DIAGNOSTICS LIMITEDIDP2023-07-26