FDA.reportPublic FDA data

Tissue-Tek® Quick-Ray™

Primary DI
00615233081797
Brand
Tissue-Tek® Quick-Ray™
Company
SAKURA FINETEK U.S.A., INC.
Model
8016
Catalog number
8016
Device description
Recipient Block, 1 mm
Published
2020-03-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00615233081797PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00615233081797006152330817976152330817970615233081797

GMDN Terms#

Term, Definition table
TermDefinition
Tissue embedding mould holder IVDA preformed plastic device intended to contain and hold a tissue embedding mould during an embedding procedure (e.g., in paraffin wax) to form a tissue solid block, which is subsequently cut into thin sections for processing and analysis of the tissue specimen. It may also be referred to as an embedding ring and typically has a writing surface to facilitate specimen identification. 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
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
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
00615233078346Tissue-Tek® NanoMold™SAKURA FINETEK U.S.A., INC.KER2020-01-27