FDA.reportPublic FDA data

Tissue-Tek®

Primary DI
00615233013743
Brand
Tissue-Tek®
Company
SAKURA FINETEK U.S.A., INC.
Model
4121
Catalog number
4121
Device description
Base Mold for Embedding Rings 16 x 16 x 6 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
00615233013743PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00615233013743006152330137436152330137430615233013743

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
00615233010803Tissue-Tek Genie®8345-M2508345-M2502026-10-23
00615233010810Tissue-Tek Genie®8346-M2508346-M2502026-10-23
00615233010834Tissue-Tek Genie®8345-C0108345-C0102026-10-23
00615233010841Tissue-Tek Genie®8346-C0108346-C0102026-10-23
00615233016409Tissue-Tek Genie®8387-C0108387-C0102026-10-23
00615233016416Tissue-Tek Genie®8387-M2508387-M2502026-10-23
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

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