FDA.reportPublic FDA data

Tissue-Tek Xpress®

Primary DI
00615233081629
Brand
Tissue-Tek Xpress®
Company
SAKURA FINETEK U.S.A., INC.
Model
7720
Catalog number
7720
Device description
x120 Rapid Tissue Processor
Published
2020-02-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00615233081629PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00615233081629006152330816296152330816290615233081629

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

Contacts#

Phone, Email table
PhoneEmail
+1(310)972-7800TS@sakuraus.com

Regulatory Flags#

DUNS number
179135769
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00615233000491Tissue-Tek Genie®8242-C0108242-C0102020-01-01
00615233000507Tissue-Tek Genie®8242-M2508242-M2502020-01-01
00615233000637Tissue-Tek Genie®8253-M2508253-M2502020-01-01
00615233000644Tissue-Tek Genie®8253-C0108253-C0102020-01-01
00615233011435Tissue-Tek Genie®8358-C0108358-C0102025-12-26
00615233011442Tissue-Tek Genie®8358-M2508358-M2502025-12-26
00615233013996Tissue-Tek Genie®8359-M2508359-M2502025-12-26
00615233014009Tissue-Tek Genie®8359-C0108359-C0102025-12-26
00615233014474Tissue-Tek Genie®8288-M2508288-M2502025-12-26
00615233014481Tissue-Tek Genie®8288-C0108288-C0102025-12-26
00615233014559Tissue-Tek Genie®8379-C0108379-C0102025-12-26
00615233014566Tissue-Tek Genie®8379-M2508379-M2502025-12-26
00615233011411Tissue-Tek Genie®8357-M2508357-M2502025-06-24
00615233011428Tissue-Tek Genie®8357-C0108357-C0102025-06-24
00615233013965Tissue-Tek Genie®8364-C0108364-C0102025-06-24
00615233013972Tissue-Tek Genie®8364-M2508364-M2502025-06-24
00615233010629Genemed®60-0226-1560-0226-152023-10-16
00615233003577Genemed®61-015461-01542023-07-05
00615233006066Genemed®60-0154-760-0154-72023-07-05
00615233008183Genemed®60-0221-1560-0221-152020-07-10

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