FDA.reportPublic FDA data

Accu-Cut® SRM™ 200

Primary DI
00615233012944
Brand
Accu-Cut® SRM™ 200
Company
SAKURA FINETEK U.S.A., INC.
Model
1437
Catalog number
1437
Device description
Low-Profile Back Plate (part of item 1435)
Published
2020-03-31
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
00615233012944PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00615233012944006152330129446152330129440615233012944

GMDN Terms#

Term, Definition table
TermDefinition
Microtome blade, reusableA flat, wedge-shaped, sharp blade intended to be mounted into a microtome to cut micro-thin slices of tissue that may either be frozen or fixed, and usually impregnated, with paraffin wax. The resulting sections are mounted onto glass slides for staining and then viewing with a microscope. The cutting edge will typically need to be sharpened at intervals. 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
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
05051663010580EprediaSHANDON DIAGNOSTICS LIMITEDIDO2025-06-11
00860012688968Clarapath™ SectionStar™Clarapath, Inc.IDO2025-02-04
00860012688944Clarapath™ SectionStar™Clarapath, Inc.IDO2024-10-22
00198168976302SectionStarClarapath, Inc.IDO2024-08-16
05051663010528EprediaSHANDON DIAGNOSTICS LIMITEDIDO2024-05-10
05051663010559EprediaSHANDON DIAGNOSTICS LIMITEDIDO2024-05-10
05051663517898EprediaSHANDON DIAGNOSTICS LIMITEDIDO2024-02-14
05051663517904EprediaSHANDON DIAGNOSTICS LIMITEDIDO2024-02-14
05051663517911EprediaSHANDON DIAGNOSTICS LIMITEDIDO2024-02-14
05051663005142EprediaSHANDON DIAGNOSTICS LIMITEDIDO2023-07-28
05051663005166EprediaSHANDON DIAGNOSTICS LIMITEDIDO2023-07-28
05051663005180EprediaSHANDON DIAGNOSTICS LIMITEDIDO2023-07-28
05051663005203EprediaSHANDON DIAGNOSTICS LIMITEDIDO2023-07-28
05051663005227EprediaSHANDON DIAGNOSTICS LIMITEDIDO2023-07-28
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
05051663010085EprediaSHANDON DIAGNOSTICS LIMITEDIDO2021-02-10
05051663010092EprediaSHANDON DIAGNOSTICS LIMITEDIDO2021-02-10
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
00615233008213Accu-Cut® SRM™ 300 LTSAKURA FINETEK U.S.A., INC.IDO2020-02-06
00615233008220Accu-Cut® SRM™ 300 LTSAKURA FINETEK U.S.A., INC.IDO2020-02-06