FDA.reportPublic FDA data

HistoCore PELORIS

Primary DI
09349458004712
Brand
HistoCore PELORIS
Company
LEICA BIOSYSTEMS MELBOURNE PTY LTD
Model
Spaced Basket Kit
Catalog number
S45.4503
Device description
Contain cassettes with specimens and are stacked into the retorts. Includes dividers to ensure cassettes are correctly spaced for optimal processing.
Published
2022-07-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IEOProcessor, Tissue, Automated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IEOProcessor, Tissue, AutomatedPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09349458004712PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09349458004712093494580047129349458004712

GMDN Terms#

Term, Definition table
TermDefinition
Tissue processor IVD, automatedA mains electricity (AC-powered) laboratory instrument intended to be used for the processing of clinical tissue specimens [e.g., fixation (encapsulation in paraffin wax), dehydration, infiltration] in preparation for subsequent cytological or histological examination. The device may be a single unit or modular assembly. The device operates with minimal technician involvement and complete automation of all procedural steps.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
753184944
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09349458005443ThermoBrite Elite Instrument3800-007000-0013800-007000-0012022-07-18
09349458005672BOND-III Processing ModuleBOND-IIIRS21.22012025-06-30
09349458005689BOND-MAX Processing ModuleBOND-MAXRS49.00512025-06-30
09349458005665BOND-PRIME automated stainerBOND-PRIMERS91.00212024-10-18
09349458005634BONDPrinter Ribbon & Labels for Cognitive Cxi (6 Pack)S21.46042024-08-02
09349458005641BONDPrinter Ribbon & Labels for Cognitive Cxi (6 Pack)S21.46102024-08-02
09349458005658BONDCognitive LabellerS21.46052024-08-02
09349458005627BONDZebra ZD421 Label Printer SpareS21.46322024-04-05
09349458005573HistoCore PELORISHistoCore PELORIS 3 Win10/I-Scan Upgrade KitB45.51202023-08-30
09349458005580HistoCore PELORISHistoCore PELORIS 3 Win10 Upgrade KitB45.51212023-08-30
09349458004811HistoCore PELORISHistoCore PELORIS 3 (100-120V)49.00052022-07-20
09349458004729HistoCore PELORISHigh Capacity Basket KitS45.45042022-07-18
09349458004736HistoCore PELORISBasket SpacedS45.45052022-07-18
09349458004743HistoCore PELORISHigh Capacity Basket (with dividers)S45.45062022-07-18
09349458005559HistoCore PELORIS HistoCore I-Scan KitS45.45072022-07-18
09349458005566HistoCore PELORIS HistoCore PELORIS 3 Barcode Scanner KitS45.45082022-07-18
09349458002657BONDZebra GX430t Label Printer SpareS21.46152022-07-20
09349458000004BOND-III processing moduleBOND-III21.22012022-07-18
09349458000011BOND-MAX Processing ModuleBOND-MAX49.00512022-07-18
09349458001261BONDBOND Mixing Stations (5 pack)S21.19712022-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09551020410009PathTezt®BIOCYTECH CORPORATION SDN. BHD.IEO2026-03-11
09551020410016PathTezt®BIOCYTECH CORPORATION SDN. BHD.IEO2026-03-11
04946433600584Tissue-VIP® 6 AISAKURA FINETEK U.S.A., INC.IEO2024-10-11
05051663518581EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-06-13
05051663518598EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-06-13
05051663518604EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-06-13
05051663517294EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-02-14
05051663517317EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-02-14
05051663517324EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-02-14
05051663517331EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-02-14
05051663517348EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-02-14
05051663517355EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-02-14
05051663517546EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-02-14
05051663517553EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-02-14
05051663517577EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-02-14
05051663517607EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-02-14
05051663517614EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-02-14
05051663517621EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-02-14
05051663517683EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-02-14
05051663517850EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-02-14
05051663517867EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-02-14
09349458005573HistoCore PELORISLEICA BIOSYSTEMS MELBOURNE PTY LTDIEO2023-08-30
09349458005580HistoCore PELORISLEICA BIOSYSTEMS MELBOURNE PTY LTDIEO2023-08-30
05051663009386EprediaSHANDON DIAGNOSTICS LIMITEDIEO2023-07-28
B92114709HistoPro®RUSHABH INSTRUMENTS, LLCIEO2022-12-18
09349458004811HistoCore PELORISLEICA BIOSYSTEMS MELBOURNE PTY LTDIEO2022-07-20
09349458004729HistoCore PELORISLEICA BIOSYSTEMS MELBOURNE PTY LTDIEO2022-07-18
09349458004736HistoCore PELORISLEICA BIOSYSTEMS MELBOURNE PTY LTDIEO2022-07-18
09349458004743HistoCore PELORISLEICA BIOSYSTEMS MELBOURNE PTY LTDIEO2022-07-18
09349458005559HistoCore PELORIS LEICA BIOSYSTEMS MELBOURNE PTY LTDIEO2022-07-18