FDA.reportPublic FDA data

FlexPath Blox

Primary DI
07640172345016
Brand
FlexPath Blox
Company
Inpeco SA
Model
FPB
Published
2026-02-11
Public version status
New
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
07640172345016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640172345016076401723450167640172345016

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
484880690
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
07640172344002FlexLab XFXX2024-07-30
07640172341001Accelerator a3600ACP2016-09-24
07640172342008Aptio AutomationAP22016-09-24
07640172340004FlexLabFLX2016-09-24
07640172343012ProTubePTB2022-02-08
07640172343005ProTubePTB2020-09-11
7640172341506Accelerator a3600ACP2016-09-24
7640172342503Aptio AutomationAP22016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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