FDA.reportPublic FDA data

Tissue-Tek® SmartWrite®

Primary DI
00615233082411
Brand
Tissue-Tek® SmartWrite®
Company
SAKURA FINETEK U.S.A., INC.
Model
9024
Catalog number
9024
Device description
2D Barcode Scanner and Stand
Published
2020-02-16
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
LXGEQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00615233082411PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00615233082411006152330824116152330824110615233082411

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory specimen barcode labelA label intended to facilitate clear and easy identification of laboratory specimens and materials (e.g., an in vitro diagnostic clinical specimen, or assay reagent). It is a colour-coded insert containing a barcode that is electronically readable with a computerized reader/scanner. 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
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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