FDA.reportPublic FDA data

Epredia

Primary DI
05051663011518
Brand
Epredia
Company
SHANDON DIAGNOSTICS LIMITED
Model
Avantik QS12 UV Cryostat-UK
Catalog number
956661-UK
Device description
Cryostat
Published
2025-11-07
Public version status
New
Distribution status
Not 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
05051663011518PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051663011518050516630115185051663011518

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
219103512
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
05051663626071EprediaLaser Embedding Cassettes - White110-01-10LMI2026-03-11
05051663626927EprediaLaser Embedding Cassettes - White110-01-10LMI2026-03-11
05051663011501EprediaAvantik QS12 Cryostat-UK956660-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
05051663517454EprediaVaristain V24-4 BasketA792100692024-02-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05051663011501EprediaSHANDON 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
05051663003650EprediaSHANDON DIAGNOSTICS LIMITEDIDP2023-07-26