FDA.reportPublic FDA data

CT520 Cryostat Microtome

Primary DI
06971182571258
Brand
CT520 Cryostat Microtome
Company
Dakewe (Shenzhen) Medical Equipment Co., Ltd.
Model
CT520
Published
2024-12-27
Public version status
New
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
06971182571258PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971182571258069711825712586971182571258

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.

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
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
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