| Primary Device ID | B201CGVM2NS0 |
| NIH Device Record Key | 9c067566-c982-473b-b590-e097764b4261 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Clear Guide VisiMARKER II Non-Sterile |
| Version Model Number | CGVM2NS |
| Catalog Number | CG-VM2-NS |
| Company DUNS | 965399905 |
| Company Name | CLEAR GUIDE MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B201CGVM2NS0 [Primary] |
| HIBCC | B201CGVM2NS1 [Package] Package: Shelf Box [15 Units] In Commercial Distribution |
| HIBCC | B201CGVM2NS2 [Package] Contains: B201CGVM2NS1 Package: Shipper Box [16 Units] In Commercial Distribution |
| HIBCC | B201CGVM2NS3 [Package] Contains: B201CGVM2NS1 Package: Mailer Box [1 Units] In Commercial Distribution |
| JAC | System, X-Ray, Film Marking, Radiographic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-12 |
| Device Publish Date | 2022-10-04 |
| 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 | 2022-10-12The device is a sterile or sterilizable (via PVP-I or similar antiseptic) accessory intended to mark a set of locations on a patient's intact, uncompromised skin. The device is also intended to mark objects in the operational field of view. The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique. |
| 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 |