FDA.reportPublic FDA data

Tissue-Tek®

Primary DI
10615233078657
Brand
Tissue-Tek®
Company
SAKURA FINETEK U.S.A., INC.
Model
4583
Catalog number
4583
Device description
O.C.T. Compound
Published
2019-12-15
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
KEQMEDIA, MOUNTING, WATER SOLUBLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KEQMedia, Mounting, Water SolublePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10615233078657PrimaryGS10
00615233078650Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1061523307865710615233078657
00615233078650006152330786506152330786500615233078650

GMDN Terms#

Term, Definition table
TermDefinition
Tissue freezing/embedding medium IVDA tissue freezing and embedding material intended to be used as an embedding matrix for the preparation and processing of frozen sections from biological tissues or clinical specimens.

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
Expiration 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
10849832001314Leica BiosystemsLeica Biosystems Richmond, Inc.KEQ2025-07-20
10849832012211Leica BiosystemsLeica Biosystems Richmond, Inc.KEQ2025-07-20
10849832012440Leica BiosystemsLeica Biosystems Richmond, Inc.KEQ2025-07-20
00849832001317Leica BiosystemsLeica Biosystems Richmond, Inc.KEQ2025-07-20
00849832012214Leica BiosystemsLeica Biosystems Richmond, Inc.KEQ2025-07-20
00849832012443Leica BiosystemsLeica Biosystems Richmond, Inc.KEQ2025-07-20
00673693168052EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693168069EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693180733EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693180740EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693180757EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693180764EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693180771EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693180832EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693218511EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693228695EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693235969EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693235976EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693235990EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693236010EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693236027EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00810047421061N/AScientific Device Laboratory, Inc.KEQ2023-01-31
00810047420323N/AScientific Device Laboratory, Inc.KEQ2023-01-30
00613647023778FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.KEQ2022-12-07
20613647023772FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.KEQ2022-12-07