FDA.reportPublic FDA data

CS500 Glass Coverslipper

Primary DI
06971182570190
Brand
CS500 Glass Coverslipper
Company
Dakewe (Shenzhen) Medical Equipment Co., Ltd.
Model
CS500
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
KIMDevice For Sealing Microsections

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KIMDevice For Sealing MicrosectionsPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971182570190PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971182570190069711825701906971182570190

GMDN Terms#

Term, Definition table
TermDefinition
Microscope slide coverslipper IVDAn automated mains electricity (AC-powered) laboratory instrument intended to be used to apply a coverslip over a microscope examination slide to protect the fixed/stained specimen from mechanical forces or environmental exposure prior to microscopic examination and/or long-term storage of the slide. The device operates with minimal technician involvement and complete automation of all procedural steps.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
554456618
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Expiration 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
069711825702066250 Cryostat Microtome62502020-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05051663517362EprediaSHANDON DIAGNOSTICS LIMITEDKIM2024-02-16
05051663517379EprediaSHANDON DIAGNOSTICS LIMITEDKIM2024-02-16
05051663517386EprediaSHANDON DIAGNOSTICS LIMITEDKIM2024-02-16
05051663517393EprediaSHANDON DIAGNOSTICS LIMITEDKIM2024-02-16
05051663517423EprediaSHANDON DIAGNOSTICS LIMITEDKIM2024-02-16
05051663517430EprediaSHANDON DIAGNOSTICS LIMITEDKIM2024-02-16
05051663517447EprediaSHANDON DIAGNOSTICS LIMITEDKIM2024-02-16
05051663517454EprediaSHANDON DIAGNOSTICS LIMITEDKIM2024-02-16
05051663517461EprediaSHANDON DIAGNOSTICS LIMITEDKIM2024-02-16
05051663517478EprediaSHANDON DIAGNOSTICS LIMITEDKIM2024-02-16
05051663517485EprediaSHANDON DIAGNOSTICS LIMITEDKIM2024-02-16
05051663517492EprediaSHANDON DIAGNOSTICS LIMITEDKIM2024-02-16
05051663517515EprediaSHANDON DIAGNOSTICS LIMITEDKIM2024-02-16
05051663517522EprediaSHANDON DIAGNOSTICS LIMITEDKIM2024-02-16
05051663517539EprediaSHANDON DIAGNOSTICS LIMITEDKIM2024-02-16
05051663517690EprediaSHANDON DIAGNOSTICS LIMITEDKIM2024-02-16
05051663517706EprediaSHANDON DIAGNOSTICS LIMITEDKIM2024-02-16
05051663517713EprediaSHANDON DIAGNOSTICS LIMITEDKIM2024-02-16
05051663517720EprediaSHANDON DIAGNOSTICS LIMITEDKIM2024-02-16
05051663517737EprediaSHANDON DIAGNOSTICS LIMITEDKIM2024-02-16
05051663517744EprediaSHANDON DIAGNOSTICS LIMITEDKIM2024-02-16
05051663517751EprediaSHANDON DIAGNOSTICS LIMITEDKIM2024-02-16
05051663517768EprediaSHANDON DIAGNOSTICS LIMITEDKIM2024-02-16
05051663517775EprediaSHANDON DIAGNOSTICS LIMITEDKIM2024-02-16
05051663517782EprediaSHANDON DIAGNOSTICS LIMITEDKIM2024-02-16
05051663517799EprediaSHANDON DIAGNOSTICS LIMITEDKIM2024-02-16
05051663517805EprediaSHANDON DIAGNOSTICS LIMITEDKIM2024-02-16
05051663517812EprediaSHANDON DIAGNOSTICS LIMITEDKIM2024-02-16
05051663517829EprediaSHANDON DIAGNOSTICS LIMITEDKIM2024-02-16
05051663517836EprediaSHANDON DIAGNOSTICS LIMITEDKIM2024-02-16