FDA.reportPublic FDA data

Basket set Leica ASP300 S

Primary DI
04049188055903
Brand
Basket set Leica ASP300 S
Company
Leica Biosystems Nussloch GmbH
Model
000000014047643576
Catalog number
14047643576
Device description
Leica Biosystems Accessory
Published
2018-12-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

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
04049188055903PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049188055903040491880559034049188055903

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4962241430chs.support@leicabiosystems.co
+4962241430chs.support@leicabiosystems.com

Regulatory Flags#

DUNS number
315539452
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049188210777ASP6025 S 230V/50-60Hz000000014049559058140495590582019-07-05
04049188210784ASP6025 S 120V/50-60Hz000000014049559068140495590682019-07-05
04049188210791ASP6025 S China000000014049559088140495590882019-07-05
04049188216397HistoCore PEGASUS000000014048858005140488580052021-11-02
04049188217769HistoCore PEGASUS Plus000000014048858007140488580072021-11-02
04049188003102Leica TP1020 VF/accessories1491020US021491020US022018-12-04
04049188003119Leica TP1020 F /accessories1491020US011491020US012018-12-04
04049188055965Leica ASP300 S000000014047643515140476435152018-12-04
04049188055972Leica ASP300 S - 230-240V000000014047643514140476435142018-12-04
04049188056146Leica ASP300 S - China000000014047643057140476430572018-12-04
04049188057334Basket, assy., large000000014047634782140476347822018-12-04
04049188058423Basket000000014047634194140476341942018-12-04
04049188087706Leica TP1020 with Chloroform000000014042242238140422422382018-11-16
04049188087843Tissue basket - Cone000000014042232564140422325642018-12-04
04049188087973Flexible tube 50x4000000000014042231975140422319752018-12-04
04049188087980Flexible tube 50x2000000000014042231974140422319742018-12-04
04049188088246Leica TP1020 (Double loading) Without vaccum/w000000014042231418140422314182018-11-16
04049188088253Leica TP1020 (Double loading) With fume control000000014042231416140422314162018-11-16
04049188088260Leica TP1020 (Double loading) With vacuum/ without fume control000000014042231414140422314142018-11-16
04049188088284Leica TP1020 (Double loading) With vacuum/ with fume control000000014042231412140422314122018-12-04

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
09349458004712HistoCore PELORISLEICA BIOSYSTEMS MELBOURNE PTY LTDIEO2022-07-18
09349458004729HistoCore PELORISLEICA BIOSYSTEMS MELBOURNE PTY LTDIEO2022-07-18
09349458004736HistoCore PELORISLEICA BIOSYSTEMS MELBOURNE PTY LTDIEO2022-07-18
09349458004743HistoCore PELORISLEICA BIOSYSTEMS MELBOURNE PTY LTDIEO2022-07-18