FDA.reportPublic FDA data

Tissue-Tek® SmartWrite®

Primary DI
00615233000149
Brand
Tissue-Tek® SmartWrite®
Company
SAKURA FINETEK U.S.A., INC.
Model
9046
Catalog number
9046
Device description
Blue Frosted Slides - Charged
Published
2020-02-06
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KEWSLIDES, MICROSCOPE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KEWSlides, MicroscopePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00615233000149PrimaryGS10
00615233000132Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00615233000149006152330001496152330001490615233000149
00615233000132006152330001326152330001320615233000132

GMDN Terms#

Term, Definition table
TermDefinition
General specimen microscopy slide IVD, single-useA glass or plastic microscopy slide intended to be used for the collection, and preservation and/or transport, of any type of clinical specimen or smear for analysis and/or other investigation. 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
10
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
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
00615233011008Tissue-Tek Prisma®49002024-10-11
04946433600584Tissue-VIP® 6 AI60422024-10-11
00615233010605Tissue-Tek Genie®8386-C0108386-C0102024-05-17
00615233010612Tissue-Tek Genie®8386-M2508386-M2502024-05-17
00615233011312Tissue-Tek Genie®8337-M2508337-M2502024-05-17
00615233011350Tissue-Tek Genie®8356-C0108356-C0102024-05-17
00615233011367Tissue-Tek Genie®8356-M2508356-M2502024-05-17
00615233011329Tissue-Tek Genie®8337-C0108337-C0102024-05-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20810050855833Microscope SlidesTYPENEX MEDICAL LLCKEW2026-03-23
00612479124448McKessonMCKESSON MEDICAL-SURGICAL INC.KEW2026-03-11
00612479124455McKessonMCKESSON MEDICAL-SURGICAL INC.KEW2026-03-11
00612479124462McKessonMCKESSON MEDICAL-SURGICAL INC.KEW2026-03-11
00612479160651McKessonMCKESSON MEDICAL-SURGICAL INC.KEW2026-03-11
00612479160668McKessonMCKESSON MEDICAL-SURGICAL INC.KEW2026-03-11
00612479160675McKessonMCKESSON MEDICAL-SURGICAL INC.KEW2026-03-11
09551020410092PathTezt®BIOCYTECH CORPORATION SDN. BHD.KEW2026-03-11
09551020410320PathTezt®BIOCYTECH CORPORATION SDN. BHD.KEW2026-03-11
09551020410337PathTezt®BIOCYTECH CORPORATION SDN. BHD.KEW2026-03-11
09551020410344PathTezt®BIOCYTECH CORPORATION SDN. BHD.KEW2026-03-11
09551020410351PathTezt®BIOCYTECH CORPORATION SDN. BHD.KEW2026-03-11
09551020410368PathTezt®BIOCYTECH CORPORATION SDN. BHD.KEW2026-03-11
20194484321585N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-11
20194484321592N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-11
20194484321530N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-09
20194484321561N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-09
20194484321578N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-09
20194484321264N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
20194484321271N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
20194484321301N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
20194484321318N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
20194484321325N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
20194484321332N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
20194484321349N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
00849832023210Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2025-07-23
00849832024170Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2025-07-23
00849832024316Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2025-07-23
00849832024323Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2025-07-23
00849832024354Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2025-07-23