FDA.reportPublic FDA data

Tissue-Tek®

Primary DI
10615233078664
Brand
Tissue-Tek®
Company
SAKURA FINETEK U.S.A., INC.
Model
4650
Catalog number
4650
Device description
Cold Plate
Published
2020-02-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IDOMICROTOME, ROTARY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IDOMicrotome, RotaryPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10615233078664PrimaryGS10
00615233078667Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1061523307866410615233078664
00615233078667006152330786676152330786670615233078667

GMDN Terms#

Term, Definition table
TermDefinition
Tissue embedding unitA mains electricity (AC-powered), electronic unit used in the laboratory for encapsulating (embedding) histologic tissue samples in liquid paraffin wax which when cooled and fixed to a sample holder can be further processed, e.g., placed in a microtome for cutting into samples for microscopy and/or for histological storage. This device will typically have a large storage capacity for the liquid paraffin (e.g., 4 litres) with heating facilities and heated work area, excess paraffin drainage facility, a cold plate area, and possibly a built-in forceps heater.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(310)972-7800TS@sakuraus.com

Regulatory Flags#

DUNS number
179135769
Device count
4
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing 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
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05051663010528EprediaSHANDON DIAGNOSTICS LIMITEDIDO2024-05-10
05051663010559EprediaSHANDON DIAGNOSTICS LIMITEDIDO2024-05-10
05051663517898EprediaSHANDON DIAGNOSTICS LIMITEDIDO2024-02-14
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05051663005241EprediaSHANDON DIAGNOSTICS LIMITEDIDO2023-07-28
05051663005258EprediaSHANDON DIAGNOSTICS LIMITEDIDO2023-07-28
06971182570978MT1 Rotary MicrotomeDakewe (Shenzhen) Medical Equipment Co., Ltd.IDO2022-06-07
05051663010443EprediaSHANDON DIAGNOSTICS LIMITEDIDO2021-02-14
05051663005128EprediaSHANDON DIAGNOSTICS LIMITEDIDO2021-02-10
05051663010078EprediaSHANDON DIAGNOSTICS LIMITEDIDO2021-02-10
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05051663010108EprediaSHANDON DIAGNOSTICS LIMITEDIDO2021-02-10
05051663010115EprediaSHANDON DIAGNOSTICS LIMITEDIDO2021-02-10
08720177655170Accu-Cut® SRM™ 200SAKURA FINETEK U.S.A., INC.IDO2020-08-21
06971182570084LS-2065 Rotary MicrotomeDakewe (Shenzhen) Medical Equipment Co., Ltd.IDO2020-08-01
069711825701452065A Auto MicrotomeDakewe (Shenzhen) Medical Equipment Co., Ltd.IDO2020-08-01
00615233012937Accu-Cut® SRM™ 200SAKURA FINETEK U.S.A., INC.IDO2020-03-31
00615233012944Accu-Cut® SRM™ 200SAKURA FINETEK U.S.A., INC.IDO2020-03-31
00615233008213Accu-Cut® SRM™ 300 LTSAKURA FINETEK U.S.A., INC.IDO2020-02-06