AccessGUDID - DEVICE: Clear Guide TP Access Frame (B201CGTPF0)

GUDID

Device Identifier (DI) Information

Brand Name: Clear Guide TP Access Frame
Version or Model: CGTPF
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CG-TPF
Company Name: CLEAR GUIDE MEDICAL, INC.

Primary DI Number: B201CGTPF0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 965399905 *Terms of Use

Device Description: The device is a configurable, manual surgical aid accessory with multi-modality fiducial markers and a needle guide grid for image-guided transperineal procedures. The device is intended to guide needle placements while keeping the patient's perineum accessible during endorectal ultrasound and MR/CT-guided interventions. The device is intended for use in a clinical setting. The device is a guide frame replacement for the Clear Guide TP Access Tool (CG-PAT).

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
64457	MRI-oriented needle guide positioner	A manually-adjustable device designed to hold and enable positioning of a needle guide using real-time magnetic resonance imaging (MRI) so that the needle can be manually inserted into a patient at a precise location/angle; it is not intended to introduce the needle. It is a frame-like device (e.g., holder with moveable plates) made of MRI-compatible materials designed to be attached to the patient’s body. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ITX	Transducer, Ultrasonic, Diagnostic
JAC	System, X-Ray, Film Marking, Radiographic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K234030	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d19215aa-e537-4415-893c-79587befb852
Public Version Date: January 20, 2025
Public Version Number: 1
DI Record Publish Date: January 10, 2025