FDA.reportPublic FDA data

Tissue-Tek® Cryo3®

Primary DI
00615233009272
Brand
Tissue-Tek® Cryo3®
Company
SAKURA FINETEK U.S.A., INC.
Model
6209
Catalog number
6209
Device description
Flex Cryostat, Mohs
Published
2020-06-20
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
IDPMICROTOME, CRYOSTAT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IDPMicrotome, CryostatPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00615233009272PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00615233009272006152330092726152330092720615233009272

GMDN Terms#

Term, Definition table
TermDefinition
Cryostat microtomeAn instrument that consists of a microtome contained in a temperature-controlled cabinet called a cryostat. The cryostat microtome allows the operator to section frozen tissue specimens without lengthy fixation procedures, thereby speeding diagnosis.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05051663011501EprediaSHANDON DIAGNOSTICS LIMITEDIDP2025-11-07
05051663011518EprediaSHANDON DIAGNOSTICS LIMITEDIDP2025-11-07
05051663011112EprediaSHANDON DIAGNOSTICS LIMITEDIDP2025-08-26
05051663011129EprediaSHANDON DIAGNOSTICS LIMITEDIDP2025-08-26
06971182571258CT520 Cryostat MicrotomeDakewe (Shenzhen) Medical Equipment Co., Ltd.IDP2024-12-27
05051663003520EprediaSHANDON DIAGNOSTICS LIMITEDIDP2024-02-15
05051663003537EprediaSHANDON DIAGNOSTICS LIMITEDIDP2024-02-15
05051663003544EprediaSHANDON DIAGNOSTICS LIMITEDIDP2024-02-15
05051663003551EprediaSHANDON DIAGNOSTICS LIMITEDIDP2024-02-15
05051663003582EprediaSHANDON DIAGNOSTICS LIMITEDIDP2024-02-15
05051663003599EprediaSHANDON DIAGNOSTICS LIMITEDIDP2024-02-15
05051663003605EprediaSHANDON DIAGNOSTICS LIMITEDIDP2024-02-15
05051663003629EprediaSHANDON DIAGNOSTICS LIMITEDIDP2024-02-15
05051663003865EprediaSHANDON DIAGNOSTICS LIMITEDIDP2024-02-15
05051663003872EprediaSHANDON DIAGNOSTICS LIMITEDIDP2024-02-15
05051663003889EprediaSHANDON DIAGNOSTICS LIMITEDIDP2023-08-09
05051663003896EprediaSHANDON DIAGNOSTICS LIMITEDIDP2023-08-09
05051663005432EprediaSHANDON DIAGNOSTICS LIMITEDIDP2023-08-09
05051663005456EprediaSHANDON DIAGNOSTICS LIMITEDIDP2023-08-09
05051663003469EprediaSHANDON DIAGNOSTICS LIMITEDIDP2023-07-26
05051663003476EprediaSHANDON DIAGNOSTICS LIMITEDIDP2023-07-26
05051663003483EprediaSHANDON DIAGNOSTICS LIMITEDIDP2023-07-26
05051663003490EprediaSHANDON DIAGNOSTICS LIMITEDIDP2023-07-26
05051663003506EprediaSHANDON DIAGNOSTICS LIMITEDIDP2023-07-26
05051663003513EprediaSHANDON DIAGNOSTICS LIMITEDIDP2023-07-26
05051663003568EprediaSHANDON DIAGNOSTICS LIMITEDIDP2023-07-26
05051663003575EprediaSHANDON DIAGNOSTICS LIMITEDIDP2023-07-26
05051663003612EprediaSHANDON DIAGNOSTICS LIMITEDIDP2023-07-26
05051663003636EprediaSHANDON DIAGNOSTICS LIMITEDIDP2023-07-26
05051663003643EprediaSHANDON DIAGNOSTICS LIMITEDIDP2023-07-26