FDA.reportPublic FDA data

Epredia

Primary DI
05051663009652
Brand
Epredia
Company
SHANDON DIAGNOSTICS LIMITED
Model
COLD MODULE
Published
2021-02-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IDWDispensers, Paraffin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IDWDispensers, ParaffinPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05051663009652PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051663009652050516630096525051663009652

GMDN Terms#

Term, Definition table
TermDefinition
Tissue embedding unit IVDAn electrically-powered, electronic unit intended to be used in the laboratory for encapsulating (embedding) histologic tissue samples in liquid paraffin wax which when cooled and fixed to a sample holder can be further processed, e.g., placed in a microtome for cutting into samples for microscopy and/or for histological storage. This device will typically have a large storage capacity for the liquid paraffin (e.g., 4 litres) with heating facilities and heated work area, excess paraffin drainage facility, a cold plate area, and possibly a built-in forceps heater.

Sterilization Methods#

Method table
Method

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
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
07640172345016FlexPath BloxInpeco SAIDW2026-02-11
05051663518161EprediaSHANDON DIAGNOSTICS LIMITEDIDW2024-02-15
05051663518178EprediaSHANDON DIAGNOSTICS LIMITEDIDW2024-02-15
05051663518185EprediaSHANDON DIAGNOSTICS LIMITEDIDW2024-02-15
05051663518192EprediaSHANDON DIAGNOSTICS LIMITEDIDW2024-02-15
05051663518208EprediaSHANDON DIAGNOSTICS LIMITEDIDW2024-02-15
05051663518215EprediaSHANDON DIAGNOSTICS LIMITEDIDW2024-02-15
05051663518222EprediaSHANDON DIAGNOSTICS LIMITEDIDW2024-02-15
05051663518239EprediaSHANDON DIAGNOSTICS LIMITEDIDW2024-02-15
05051663518246EprediaSHANDON DIAGNOSTICS LIMITEDIDW2024-02-15
05051663518307EprediaSHANDON DIAGNOSTICS LIMITEDIDW2024-02-15
05051663518314EprediaSHANDON DIAGNOSTICS LIMITEDIDW2024-02-15
B921119650HistoPro®RUSHABH INSTRUMENTS, LLCIDW2022-12-18
B921119651HistoPro®RUSHABH INSTRUMENTS, LLCIDW2022-12-18
B921119660HistoPro®RUSHABH INSTRUMENTS, LLCIDW2022-12-18
B921119661HistoPro®RUSHABH INSTRUMENTS, LLCIDW2022-12-18
B92114667HistoPro®RUSHABH INSTRUMENTS, LLCIDW2022-12-18
B92114668HistoPro®RUSHABH INSTRUMENTS, LLCIDW2022-12-18
B92114669HistoPro®RUSHABH INSTRUMENTS, LLCIDW2022-12-18
B92114670HistoPro®RUSHABH INSTRUMENTS, LLCIDW2022-12-18
05051663009614EprediaSHANDON DIAGNOSTICS LIMITEDIDW2021-02-10
05051663009621EprediaSHANDON DIAGNOSTICS LIMITEDIDW2021-02-10
05051663009638EprediaSHANDON DIAGNOSTICS LIMITEDIDW2021-02-10
05051663009645EprediaSHANDON DIAGNOSTICS LIMITEDIDW2021-02-10
05051663009669EprediaSHANDON DIAGNOSTICS LIMITEDIDW2021-02-10
05051663009676EprediaSHANDON DIAGNOSTICS LIMITEDIDW2021-02-10
05051663009683EprediaSHANDON DIAGNOSTICS LIMITEDIDW2021-02-10
05051663002288Thermo FisherSHANDON DIAGNOSTICS LIMITEDIDW2020-09-30
05051663002295Thermo FisherSHANDON DIAGNOSTICS LIMITEDIDW2020-09-25
05051663002301Thermo FisherSHANDON DIAGNOSTICS LIMITEDIDW2020-09-17