ClaraTape™ Transfer Tape

Basic Information

• Brand Name: ClaraTape™ Transfer Tape
• Primary DI: 00860012688906
• Version / Model: 900-00020
• Company Name: Clarapath, Inc.
• Labeler DUNS: 079469240
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-23
• Public Version: 1
• Public Version Date: 2024-09-02
• Public Version Status: New
• Public Device Record Key: 15d83232-8999-49d5-ada2-baf325e479a6

Device Description

Clarapath tape is intended to assist in the cutting and transfer of tissue sections in SectionStar™ auto-sectioning machine

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IDL	Microtome, Accessories	Pathology	864.3010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15158	Rotary microtome IVD	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10860012688903	GS1		45	In Commercial Distribution
Primary	00860012688906	GS1