| Primary Device ID | B201CGSG0 |
| NIH Device Record Key | fc0f0ac8-8948-4002-9069-ef4f5b47945d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Clear Guide SteriGRID |
| Version Model Number | CGSG |
| Catalog Number | CG-SG |
| Company DUNS | 965399905 |
| Company Name | CLEAR GUIDE MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1 (443) 267-7661 |
| support@clearguidemedical.com | |
| Phone | +1 (443) 267-7661 |
| support@clearguidemedical.com | |
| Phone | +1 (443) 267-7661 |
| support@clearguidemedical.com | |
| Phone | +1 (443) 267-7661 |
| support@clearguidemedical.com | |
| Phone | +1 (443) 267-7661 |
| support@clearguidemedical.com | |
| Phone | +1 (443) 267-7661 |
| support@clearguidemedical.com | |
| Phone | +1 (443) 267-7661 |
| support@clearguidemedical.com | |
| Phone | +1 (443) 267-7661 |
| support@clearguidemedical.com | |
| Phone | +1 (443) 267-7661 |
| support@clearguidemedical.com | |
| Phone | +1 (443) 267-7661 |
| support@clearguidemedical.com | |
| Phone | +1 (443) 267-7661 |
| support@clearguidemedical.com | |
| Phone | +1 (443) 267-7661 |
| support@clearguidemedical.com | |
| Phone | +1 (443) 267-7661 |
| support@clearguidemedical.com |
| Needle Gauge | 14 Gauge |
| Needle Gauge | 14 Gauge |
| Needle Gauge | 14 Gauge |
| Needle Gauge | 14 Gauge |
| Needle Gauge | 14 Gauge |
| Needle Gauge | 14 Gauge |
| Needle Gauge | 14 Gauge |
| Needle Gauge | 14 Gauge |
| Needle Gauge | 14 Gauge |
| Needle Gauge | 14 Gauge |
| Needle Gauge | 14 Gauge |
| Needle Gauge | 14 Gauge |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B201CGSG0 [Primary] |
| HIBCC | B201CGSG1 [Package] Package: Unit Box [1 Units] In Commercial Distribution |
| HIBCC | B201CGSG2 [Package] Contains: B201CGSG1 Package: Packer Shelf Box [4 Units] In Commercial Distribution |
| HIBCC | B201CGSG3 [Package] Contains: B201CGSG2 Package: Mailer Box [1 Units] In Commercial Distribution |
| HIBCC | B201CGSG4 [Package] Contains: B201CGSG2 Package: Shipper Box [16 Units] In Commercial Distribution |
| ITX | Transducer, Ultrasonic, Diagnostic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-01-20 |
| Device Publish Date | 2025-01-10 |
| B201CGPAT0 - Clear Guide TP Access Tool | 2025-01-20 The device is a configurable, manual surgical aid accessory with multi-modality fiducial markers and a needle guide grid for ima |
| B201CGSCENERGYTP0 - Clear Guide SCENERGY TP | 2025-01-20 The Clear Guide SCENERGY is software that provides fusion of images from Computed Tomography (CT), Magnetic Resonance (MR), and |
| B201CGSG0 - Clear Guide SteriGRID | 2025-01-20The 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) |
| B201CGSG0 - Clear Guide SteriGRID | 2025-01-20 The device is a needle guide grid for image-guided transperineal procedures. The device is intended to guide needle placements d |
| B201CGTPF0 - Clear Guide TP Access Frame | 2025-01-20 The device is a configurable, manual surgical aid accessory with multi-modality fiducial markers and a needle guide grid for ima |
| B201CGTPP0 - Clear Guide TP Access Posts | 2025-01-20 The device is a configurable, manual surgical aid accessory with multi-modality fiducial markers and a needle guide grid for ima |
| B201CGCORE170 - Clear Guide CORE | 2022-10-17 The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR G |
| B201CGCORE240 - Clear Guide CORE | 2022-10-17 The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR G |
| B201CGOHM0 - Clear Guide Optical Head | 2022-10-17 The device is intended as an accessory hardware to provide input into medical device software by capturing video and other senso |