FDA.reportPublic FDA data

Tissue-Tek®

Primary DI
00615233078124
Brand
Tissue-Tek®
Company
SAKURA FINETEK U.S.A., INC.
Model
4165
Catalog number
4165
Device description
Base Mold 37 x 24 x 5 mm
Published
2019-12-25
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
KERCONTAINER, EMBEDDING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KERContainer, EmbeddingPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00615233078124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00615233078124006152330781246152330781240615233078124

GMDN Terms#

Term, Definition table
TermDefinition
Tissue embedding mould IVD, reusableA metal container of square or rectangular shape intended to be used to embed tissue specimens into an embedding medium (e.g., paraffin wax) to form a solid block, which is subsequently cut into thin sections for processing and analysis of the tissue specimen. It is typically made of stainless steel. 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
1
DM exempt
true
Premarket exempt
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
06971182571166Embedding CassetteDakewe (Shenzhen) Medical Equipment Co., Ltd.KER2024-12-27
06971182571173Embedding CassetteDakewe (Shenzhen) Medical Equipment Co., Ltd.KER2024-12-27
06971182571180Embedding CassetteDakewe (Shenzhen) Medical Equipment Co., Ltd.KER2024-12-27
06971182571197Embedding CassetteDakewe (Shenzhen) Medical Equipment Co., Ltd.KER2024-12-27
00673693227506EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKER2024-10-08
00673693227513EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKER2024-10-08
00673693227520EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKER2024-10-08
00673693227537EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKER2024-10-08
00673693214254EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKER2024-08-02
00673693218368EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKER2024-08-02
00673693219310EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKER2024-08-02
00673693219327EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKER2024-08-02
00673693220460EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKER2024-08-02
00673693224130EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKER2024-08-02
00673693224147EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKER2024-08-02
00673693224154EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKER2024-08-02
00673693083751EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKER2024-08-01
00673693083768EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKER2024-08-01
00673693083775EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKER2024-08-01
00673693083782EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKER2024-08-01
00673693224116EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKER2024-08-01
00673693224123EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKER2024-08-01
00615233081735Tissue-Tek® Quick-Ray™SAKURA FINETEK U.S.A., INC.KER2020-03-17
00615233081797Tissue-Tek® Quick-Ray™SAKURA FINETEK U.S.A., INC.KER2020-03-17
00615233081803Tissue-Tek® Quick-Ray™SAKURA FINETEK U.S.A., INC.KER2020-03-17
00615233081810Tissue-Tek® Quick-Ray™SAKURA FINETEK U.S.A., INC.KER2020-03-17
00615233081827Tissue-Tek® Quick-Ray™SAKURA FINETEK U.S.A., INC.KER2020-03-17
00615233081834Tissue-Tek® Quick-Ray™SAKURA FINETEK U.S.A., INC.KER2020-03-17
10615233078770Cryomold®SAKURA FINETEK U.S.A., INC.KER2020-03-17
10615233078787Cryomold®SAKURA FINETEK U.S.A., INC.KER2020-03-17