FDA UDI
In Commercial Distribution
🇺🇸 United States
Clear Guide SteriGRID
DI: B201CGSG0
·
Model: CGSG
·
CLEAR GUIDE MEDICAL, INC.
Product Codes
2
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
Basic Information
- Brand Name
- Clear Guide SteriGRID
- Primary DI
- B201CGSG0
- Version / Model
- CGSG
- Catalog Number
- CG-SG
- 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
- fc0f0ac8-8948-4002-9069-ef4f5b47945d
Device Description
The device is a needle guide grid for image-guided transperineal procedures. The device is intended to guide needle placements during endorectal ultrasound and MR/CT-guided interventions. The device is intended for use in a clinical setting. The device is intended as a disposable accessory to Clear Guide TP Access Tool (CG-PAT)
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
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | 892.1570 | 2 |
| IWJ | System, Applicator, Radionuclide, Manual | Radiology | 892.5650 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45018 | Needle guide, single-use | A rigid, non-powered device designed to direct a sharp needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for different procedures such as urethral injections, image-guided (e.g., ultrasound, MRI) transrectal/transperineal prostate biopsy or ablation, endocavity IVF procedures, percutaneous punctures, nerve blocks, electromagnetic device tracking surgery, and stereotactic breast biopsies. Procedural supportive devices (e.g., ultrasound transducer cover/sheath, drape) 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 |
|---|---|---|---|---|---|---|
| Primary | B201CGSG0 | HIBCC | ||||
| Package | B201CGSG1 | HIBCC | Unit Box | 1 | In Commercial Distribution | |
| Package | B201CGSG2 | HIBCC | Packer Shelf Box | 4 | In Commercial Distribution | |
| Package | B201CGSG3 | HIBCC | Mailer Box | 1 | In Commercial Distribution | |
| Package | B201CGSG4 | HIBCC | Shipper Box | 16 | In Commercial Distribution |
Customer Contacts
- Phone
- +1 (443) 267-7661
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K234030 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 14 | Gauge |