FDA.reportPublic FDA data

Tissue-Tek Prisma®

Primary DI
00615233080585
Brand
Tissue-Tek Prisma®
Company
SAKURA FINETEK U.S.A., INC.
Model
6168
Catalog number
6168
Device description
Tissue-Tek Prisma® Link Between Tissue-Tek Prisma® and Tissue-Tek® Glas™ g2
Published
2020-03-17
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
00615233080585PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00615233080585006152330805856152330805850615233080585

GMDN Terms#

Term, Definition table
TermDefinition
Microscope slide coverslipper IVDAn automated mains electricity (AC-powered) laboratory instrument intended to be used to apply a coverslip over a microscope examination slide to protect the fixed/stained specimen from mechanical forces or environmental exposure prior to microscopic examination and/or long-term storage of the slide. 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
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
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
10615233078602Tissue-Tek®SAKURA FINETEK U.S.A., INC.KIO2020-01-22