FDA.reportPublic FDA data

Histo-Tek®

Primary DI
00615233082770
Brand
Histo-Tek®
Company
SAKURA FINETEK U.S.A., INC.
Model
9234
Catalog number
9234
Device description
Biopsy Cassettes with Lid Attached , Gray
Published
2019-12-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IDZCASSETTES, TISSUE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IDZCassettes, TissuePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00615233082770PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00615233082770006152330827706152330827700615233082770

GMDN Terms#

Term, Definition table
TermDefinition
Histological tissue cassette IVDA small device intended to be used in the laboratory to support/contain clinical tissue specimens (e.g., biopsy samples) to facilitate specimen processing [e.g., fixation (encapsulation in paraffin wax), dehydration, infiltration] in preparation for subsequent cytological or histological examination, and storage. It is in the form of a synthetic polymer container, with or without a lid, with drainage holes to maximize fluid exposure during tissue submersion in a parent device into which the container is loaded. This is a single-use device.

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
Lot or batch
true
Manufacturing date on label
true

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
05051663626927EprediaSHANDON DIAGNOSTICS LIMITEDIDZ2026-03-11
20194484321660N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-11
20194484321677N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-11
20194484321684N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-11
20194484321691N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-11
20194484321707N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-11
20194484321714N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-11
20194484321752N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-11
20194484321219N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-08
20194484321226N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-08
20194484321356N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-08
20194484321363N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-08
20194484321370N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-08
20194484321387N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-08
20194484321394N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-08
20194484321400N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-08
00849832001003Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
00849832001010Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
00849832001027Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
00849832001034Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
00849832001041Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
00849832001058Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
00849832003090Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
00849832025818Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
00849832025825Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
00849832025832Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
00849832000808Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-20
00849832002567Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-20
00849832002918Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-20
00849832002925Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-20