| Primary Device ID | B201CGONE1 |
| NIH Device Record Key | 7714baa1-8e3b-429d-9468-f1a8523c945b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Clear Guide ONE |
| Version Model Number | CGONE |
| Company DUNS | 965399905 |
| Company Name | CLEAR GUIDE MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B201CGONE0 [Primary] |
| HIBCC | B201CGONE1 [Package] Contains: B201CGONE0 Package: [1 Units] In Commercial Distribution |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-21 |
| 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 |
| B201CGCORE130 - Clear Guide CORE | 2022-10-14 The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR G |
| B201CGCORE24MR0 - Clear Guide CORE | 2022-10-14 The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR G |
| B201CGVM20 - Clear Guide VisiMARKER II | 2022-10-12 The device is a sterile or sterilizable (via PVP-I or similar antiseptic) accessory intended to mark a set of locations on a pat |
| B201CGVM2NS0 - Clear Guide VisiMARKER II Non-Sterile | 2022-10-12 The device is a sterile or sterilizable (via PVP-I or similar antiseptic) accessory intended to mark a set of locations on a pat |
| B201CGVMNS0 - Clear Guide VisiMARKER Non-Sterile | 2022-10-12 The device is a sterile or sterilizable (via PVP-I or similar antiseptic) accessory intended to mark a set of locations on a pat |