FDA.reportPublic FDA data

Tissue-Tek®

Primary DI
00615233013750
Brand
Tissue-Tek®
Company
SAKURA FINETEK U.S.A., INC.
Model
4122
Catalog number
4122
Device description
Base Mold for Embedding Rings 22 x 22 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
Rx
false
OTC
false
Sterile
false
Single use
false

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
00615233013750PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00615233013750006152330137506152330137500615233013750

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
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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
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
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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