FDA.reportPublic FDA data

Accu-Cut® SRM™ 200

Primary DI
08720177655170
Brand
Accu-Cut® SRM™ 200
Company
SAKURA FINETEK U.S.A., INC.
Model
1429
Catalog number
1429
Device description
Rotary Microtome (Retracting)
Published
2020-08-21
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
08720177655170PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08720177655170087201776551708720177655170

GMDN Terms#

Term, Definition table
TermDefinition
Rotary microtomeA microtome designed for cutting sections of tissue samples into thin slices. The sample is usually secured (fixed) in paraffin wax prior to cutting. The sections are cut by each turn of its flywheel.

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
Serial number
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

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Primary DI, Brand, Company table
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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
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05051663010115EprediaSHANDON DIAGNOSTICS LIMITEDIDO2021-02-10
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
00615233008220Accu-Cut® SRM™ 300 LTSAKURA FINETEK U.S.A., INC.IDO2020-02-06