FDA.reportPublic FDA data

ClaraBond™ Slide Coater Adhesive

Primary DI
00860012688920
Brand
ClaraBond™ Slide Coater Adhesive
Company
Clarapath, Inc.
Model
900-00021
Device description
Clarapath adhesive is intended to assist in the tissue transfer from the tape onto an unsoiled histology slide in SectionStar™ auto-sectioning machine.
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
10860012688927PackageGS132In Commercial Distribution
00860012688920PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086001268892710860012688927
00860012688920008600126889208600126889200860012688920

GMDN Terms#

Term, Definition table
TermDefinition
Rotary microtome IVDA precision cutting instrument intended to be used to cut tissue sections, fixed in paraffin wax, into thin slices for subsequent in vitro diagnostic analysis. The device has a vertically-fixed knife which cuts through the paraffin block vertically, and a flywheel mechanism which cuts sections with each turn.

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
00860012688913ClaraCut™ Blades900-000222024-08-23
00860012688937ClaraMount™ Coverslip mounting medium900-000232024-08-23

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