FDA.reportPublic FDA data

HistoPro®

Primary DI
B92114669
Brand
HistoPro®
Company
RUSHABH INSTRUMENTS, LLC
Model
650H, 230V
Catalog number
14669
Device description
Tissue Embedding Center, Hot Module, 230V
Published
2022-12-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
B92114669PrimaryHIBCC0

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.

Contacts#

Phone, Email table
PhoneEmail
2154910081wecare@rushabhinstruments.com

Regulatory Flags#

DUNS number
161907139
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B921119650HistoPro®150H, 115V1196502022-12-18
B921119651HistoPro®150H, 230V1196512022-12-18
B921119660HistoPro®150CS, 115V1196602022-12-18
B921119661HistoPro®150CS, 230V1196612022-12-18
B92112631HistoPro®3030, 115V126312022-12-17
B92112691HistoPro®3030, 230V126912022-12-17
B92113917HistoPro®2430139172022-12-17
B92114667HistoPro®650H, 115V146672022-12-18
B92114668HistoPro®650CS, 115V146682022-12-18
B92114670HistoPro®650CS, 230V146702022-12-18
B92114709HistoPro®600147092022-12-18
B92115391HistoPro®620153912022-12-17
B92113401HistoPro®414134012022-12-04

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
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
05051663009652EprediaSHANDON 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