FDA.reportPublic FDA data

ClaraCut™ Blades

Primary DI
00860012688913
Brand
ClaraCut™ Blades
Company
Clarapath, Inc.
Model
900-00022
Device description
Microtome blade cartridge for use in SectionStar™ auto-sectioning machine for the preparation of pathology specimens.Microtome blades are used for sectioning a variety of sample types, including fixed, paraffin embedded cell and tissue blocks.
Published
2024-08-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
IDLMicrotome, Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IDLMicrotome, AccessoriesPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860012688910PackageGS112In Commercial Distribution
00860012688913PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086001268891010860012688910
00860012688913008600126889138600126889130860012688913

GMDN Terms#

Term, Definition table
TermDefinition
Microtome blade IVD, single-useA flat, wedge-shaped, sharp blade intended to be mounted into a microtome to cut micro-thin slices of tissue that has been fixed, and usually impregnated, with paraffin wax. The resulting sections are mounted onto slides for staining and then viewing with a microscope. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079469240
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860012688968Clarapath™ SectionStar™810-000022025-02-04
00860012688944Clarapath™ SectionStar™810-000012024-10-22
00198168976302SectionStar810-000012024-08-16
00860012688906ClaraTape™ Transfer Tape900-000202024-08-23
10860012688903ClaraTape™ Transfer Tape900-000202024-08-23
00860012688920ClaraBond™ Slide Coater Adhesive900-000212024-08-23
00860012688937ClaraMount™ Coverslip mounting medium900-000232024-08-23

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