FDA.reportPublic FDA data

Tissue-Tek®

Primary DI
10615233078602
Brand
Tissue-Tek®
Company
SAKURA FINETEK U.S.A., INC.
Model
4465
Catalog number
4465
Device description
24 - Slide Holder with Handle
Published
2020-01-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KIOSLIDE STAINER, IMMERSION TYPE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KIOSlide Stainer, Immersion TypePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10615233078602PrimaryGS10
00615233078605Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1061523307860210615233078602
00615233078605006152330786056152330786050615233078605

GMDN Terms#

Term, Definition table
TermDefinition
Microscope slide holder, preparation/stainingA holder used in the laboratory to hold microscope slides in an upright position during the preparation or staining procedures. It is typically made of plastic materials, will sit sturdily upon a flat surface (e.g., a laboratory bench top or on a shelf) and has a series of spaced slots into which the slides are placed. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
179135769
Device count
12
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
00615233080332Tissue-Tek Prisma®SAKURA FINETEK U.S.A., INC.KIO2020-03-17
00615233080585Tissue-Tek Prisma®SAKURA FINETEK U.S.A., INC.KIO2020-03-17
00615233078575Tissue-Tek®SAKURA FINETEK U.S.A., INC.KIO2020-01-22
00615233078582Tissue-Tek®SAKURA FINETEK U.S.A., INC.KIO2020-01-22
00615233078599Tissue-Tek®SAKURA FINETEK U.S.A., INC.KIO2020-01-22