FDA.reportPublic FDA data

Epredia

Primary DI
05051663005227
Brand
Epredia
Company
SHANDON DIAGNOSTICS LIMITED
Model
HM355 S Microtome
Published
2023-07-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IDOMicrotome, Rotary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IDOMicrotome, RotaryPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05051663005227PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051663005227050516630052275051663005227

GMDN Terms#

Term, Definition table
TermDefinition
Rotary microtome IVDA precision cutting instrument intended to be used to cut tissue sections, fixed in paraffin wax, into thin slices for subsequent in vitro diagnostic analysis. The device has a vertically-fixed knife which cuts through the paraffin block vertically, and a flywheel mechanism which cuts sections with each turn.

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
05051663010580EprediaSHANDON DIAGNOSTICS LIMITEDIDO2025-06-11
00860012688968Clarapath™ SectionStar™Clarapath, Inc.IDO2025-02-04
00860012688944Clarapath™ SectionStar™Clarapath, Inc.IDO2024-10-22
00198168976302SectionStarClarapath, Inc.IDO2024-08-16
05051663010528EprediaSHANDON DIAGNOSTICS LIMITEDIDO2024-05-10
05051663010559EprediaSHANDON DIAGNOSTICS LIMITEDIDO2024-05-10
05051663517898EprediaSHANDON DIAGNOSTICS LIMITEDIDO2024-02-14
05051663517904EprediaSHANDON DIAGNOSTICS LIMITEDIDO2024-02-14
05051663517911EprediaSHANDON DIAGNOSTICS LIMITEDIDO2024-02-14
05051663005142EprediaSHANDON DIAGNOSTICS LIMITEDIDO2023-07-28
05051663005166EprediaSHANDON DIAGNOSTICS LIMITEDIDO2023-07-28
05051663005180EprediaSHANDON DIAGNOSTICS LIMITEDIDO2023-07-28
05051663005203EprediaSHANDON DIAGNOSTICS LIMITEDIDO2023-07-28
05051663005241EprediaSHANDON DIAGNOSTICS LIMITEDIDO2023-07-28
05051663005258EprediaSHANDON DIAGNOSTICS LIMITEDIDO2023-07-28
06971182570978MT1 Rotary MicrotomeDakewe (Shenzhen) Medical Equipment Co., Ltd.IDO2022-06-07
05051663010443EprediaSHANDON DIAGNOSTICS LIMITEDIDO2021-02-14
05051663005128EprediaSHANDON DIAGNOSTICS LIMITEDIDO2021-02-10
05051663010078EprediaSHANDON DIAGNOSTICS LIMITEDIDO2021-02-10
05051663010085EprediaSHANDON DIAGNOSTICS LIMITEDIDO2021-02-10
05051663010092EprediaSHANDON DIAGNOSTICS LIMITEDIDO2021-02-10
05051663010108EprediaSHANDON DIAGNOSTICS LIMITEDIDO2021-02-10
05051663010115EprediaSHANDON DIAGNOSTICS LIMITEDIDO2021-02-10
08720177655170Accu-Cut® SRM™ 200SAKURA FINETEK U.S.A., INC.IDO2020-08-21
06971182570084LS-2065 Rotary MicrotomeDakewe (Shenzhen) Medical Equipment Co., Ltd.IDO2020-08-01
069711825701452065A Auto MicrotomeDakewe (Shenzhen) Medical Equipment Co., Ltd.IDO2020-08-01
00615233012937Accu-Cut® SRM™ 200SAKURA FINETEK U.S.A., INC.IDO2020-03-31
00615233012944Accu-Cut® SRM™ 200SAKURA FINETEK U.S.A., INC.IDO2020-03-31
00615233008213Accu-Cut® SRM™ 300 LTSAKURA FINETEK U.S.A., INC.IDO2020-02-06
00615233008220Accu-Cut® SRM™ 300 LTSAKURA FINETEK U.S.A., INC.IDO2020-02-06