FDA.reportPublic FDA data

ClaraTape™ Transfer Tape

Primary DI
00860012688906
Brand
ClaraTape™ Transfer Tape
Company
Clarapath, Inc.
Model
900-00020
Device description
Clarapath tape is intended to assist in the cutting and transfer of tissue sections 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
10860012688903PackageGS145In Commercial Distribution
00860012688906PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086001268890310860012688903
00860012688906008600126889068600126889060860012688906

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.

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
10860012688903ClaraTape™ Transfer Tape900-000202024-08-23
00860012688913ClaraCut™ Blades900-000222024-08-23
00860012688920ClaraBond™ Slide Coater Adhesive900-000212024-08-23
00860012688937ClaraMount™ Coverslip mounting medium900-000232024-08-23

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Primary DI, Brand, Company table
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