FDA UDI
In Commercial Distribution
🇺🇸 United States
Clear Guide TP Access Frame
DI: B201CGTPF0
·
Model: CGTPF
·
CLEAR GUIDE MEDICAL, INC.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Clear Guide TP Access Frame
- Primary DI
- B201CGTPF0
- Version / Model
- CGTPF
- Catalog Number
- CG-TPF
- Company Name
- CLEAR GUIDE MEDICAL, INC.
- Labeler DUNS
- 965399905
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-10
- Public Version
- 1
- Public Version Date
- 2025-01-20
- Public Version Status
- New
- Public Device Record Key
- d19215aa-e537-4415-893c-79587befb852
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
- Single Use
- No
- 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
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | 892.1570 | 2 |
| JAC | System, X-Ray, Film Marking, Radiographic | Radiology | 892.1640 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B201CGTPF0 | HIBCC | ||||
| Package | B201CGTPF1 | HIBCC | Shelf Box | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- +1 (443) 267-7661
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K234030 | 000 |