Clear Guide TipTAG

Basic Information

• Brand Name: Clear Guide TipTAG
• Primary DI: B201CGTT0
• Version / Model: CGTT
• Company Name: CLEAR GUIDE MEDICAL, INC.
• Labeler DUNS: 965399905
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-04-07
• Public Version: 5
• Public Version Date: 2023-11-03
• Public Version Status: Update
• Public Device Record Key: 40bbefbb-6388-4fc4-9a01-2a5614400d52

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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JAC	System, X-Ray, Film Marking, Radiographic	Radiology	892.1640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47020	Imaging lesion localization marker, external, single-use	A device placed on the surface of a patient's body during a surgical procedure to create identifying marks that can be seen on radiographic film or digital images for the localization and delineation of areas of interest (e.g., a tumour or lesion), or attached to navigated instruments used to assist in computer-assisted surgery. It is made from materials compatible with the imaging system in which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, nuclear medicine], or as reflective markers detected by the cameras/computer software of an image guided surgery/patient positioning system (PPS). This is a single-use device.	No	Obsolete
65388	Surgical optical-tracking spatial marker, single-use	A non-powered, noninvasive component of a surgical navigation and/or device tracking system (e.g., computer-assisted surgical ultrasound system, surgical microscope) intended for preoperative and/or intraoperative use to function as an optical reference to enable spatial registration/tracking of the position/movement/size of a patient, another marker and/or surgical instrument (e.g., stereotactic surgery probe). It may be attached to the patient, another marker or surgical instrument, and may contain features (e.g., reflective spheres, contrast patterns) detectable by a tracking camera. Procedural supportive devices (e.g., drapes) may be included with the device. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B201CGTT1	HIBCC		10	In Commercial Distribution
Primary	B201CGTT0	HIBCC
Package	B201CGTT2	HIBCC	Shipper Box	4	In Commercial Distribution