FDA.reportPublic FDA data

Epredia

Primary DI
05051663517522
Brand
Epredia
Company
SHANDON DIAGNOSTICS LIMITED
Model
Barcode Reader Conversion
Catalog number
A79210200
Device description
ClearVue coverslipper- Accessory
Published
2024-02-16
Public version status
New
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
05051663517522PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051663517522050516635175225051663517522

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
219103512
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05051663626071EprediaLaser Embedding Cassettes - White110-01-10LMI2026-03-11
05051663626927EprediaLaser Embedding Cassettes - White110-01-10LMI2026-03-11
05051663011501EprediaAvantik QS12 Cryostat-UK956660-UK2025-11-07
05051663011518EprediaAvantik QS12 UV Cryostat-UK956661-UK2025-11-07
05051663011112EprediaHM525 NX Cryostat-UK956640-UK 2025-08-26
05051663011129EprediaHM525 NX UV Cryostat-UK956641-UK2025-08-26
05051663010580EprediaHM 355S Rotary Microtome-UK905200-UK2025-06-11
05051663010467EprediaE1000 Dx Digital Pathology Solution A85200002 2025-03-10
05051663518581EprediaRevos Chamber Filter Assembly KitA841101552024-06-13
05051663518598EprediaChamber Filter Tool KitA841101562024-06-13
05051663518604EprediaNose Cone Extraction Tool KitA841101572024-06-13
05051663010528EprediaHM 325 Rotary Microtome (UK made)902100-UK2024-05-10
05051663010559EprediaHM 340E Rotary Microtome (UK made)905190-UK 2024-05-10
05051663517362EprediaSLIP HOPPER 24x40mm #1.5A792100502024-02-16
05051663517379EprediaSLIP HOPPER 24x50mm #1.5A792100512024-02-16
05051663517386EprediaSLIP HOPPER 24x55mm #1.5A792100522024-02-16
05051663517393EprediaBasket Stand CompleteA792100562024-02-16
05051663517423EprediaSakura DRS2000 Basket (5)A792100662024-02-16
05051663517430EprediaSakura DRS2000 Basket (5)A792100672024-02-16
05051663517447EprediaSakura DRS2000 Basket (5)A792100682024-02-16

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
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
05051663517843EprediaSHANDON DIAGNOSTICS LIMITEDKIM2024-02-16