| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | B201CGCORE24MR0 | CGCORE24MR | CG-CORE24-MR | The device is intended as a computer platform to perform computation, display, c The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE24-MR model is a modified version of CG-CORE24 with significantly reduced ferromagnetic components internally. | JAK | System, X-Ray, Tomography, Computed | Clear Guide CORE | |
| 2 | B201CGCORE240 | CGCORE24 | CG-CORE24 | The device is intended as a computer platform to perform computation, display, c The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE24 model is a panel PC with a 24" screen. | JAK | System, X-Ray, Tomography, Computed | Clear Guide CORE | |
| 3 | B201CGCORE170 | CGCORE17 | CG-CORE17 | The device is intended as a computer platform to perform computation, display, c The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE17 model is a panel PC with a 17" screen. | IYO | System, Imaging, Pulsed Echo, Ultrasonic | Clear Guide CORE | |
| 4 | B201CGCORE130 | CGCORE13 | CG-CORE-13 | The device is intended as a computer platform to perform computation, display, c The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE13 model is a tablet PC with a 13" screen. | JAK | System, X-Ray, Tomography, Computed | Clear Guide CORE | |
| 5 | B201CGVMNS0 | CGVMNS | CG-VM-NS | The device is a sterile or sterilizable (via PVP-I or similar antiseptic) access The 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. | JAC | System, X-Ray, Film Marking, Radiographic | Clear Guide VisiMARKER Non-Sterile | |
| 6 | B201CGSCENERGY0 | CGSCENERGY | JAK | System, X-Ray, Tomography, Computed | 2 | Clear Guide SCENERGY | ||
| 7 | B201CGVM2NS0 | CGVM2NS | CG-VM2-NS | The device is a sterile or sterilizable (via PVP-I or similar antiseptic) access The 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. | JAC | System, X-Ray, Film Marking, Radiographic | Clear Guide VisiMARKER II Non-Sterile | |
| 8 | B201CGVM20 | CGVM2 | CG-VM2 | The device is a sterile or sterilizable (via PVP-I or similar antiseptic) access The 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. | JAC | System, X-Ray, Film Marking, Radiographic | Clear Guide VisiMARKER II | |
| 9 | B201CGVM0 | CGVM | The device is a sterile or sterilizable (via PVP-I or similar antiseptic) access The 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. | JAC | System, X-Ray, Film Marking, Radiographic | Clear Guide VisiMARKER | ||
| 10 | B201CGSMM0 | CGSMM | CG-SM-M | The device is a sterile accessory intended to provide a sterile barrier for medi The device is a sterile accessory intended to provide a sterile barrier for medical procedures that require sterility and utilize the Clear Guide SuperPROBE (customer's ultrasound probe with Clear Guide Optical Head). The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique. Device is packaged together with one sterile gel packet. | PUI | Drape, Surgical, Exempt | Clear Guide SteriMASK | |
| 11 | B201CGSM0 | CGSM | The device is a sterile accessory intended to provide a sterile barrier for medi The device is a sterile accessory intended to provide a sterile barrier for medical procedures that require sterility and utilize the Clear Guide SuperPROBE (customer's ultrasound probe with Clear Guide Optical Head). The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique. | PUI | Drape, Surgical, Exempt | 2 | Clear Guide SteriMASK | |
| 12 | B201CGTT0 | CGTT | JAC | System, X-Ray, Film Marking, Radiographic | Clear Guide TipTAG | |||
| 13 | B201CGOHM0 | CGOHM | CG-OH-M | The device is intended as an accessory hardware to provide input into medical de The device is intended as an accessory hardware to provide input into medical device software by capturing video and other sensory information from the operational field for purposes of future processing. The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. | IYO,JAK | System, Imaging, Pulsed Echo, Ultrasonic,System, X-Ray, Tomography, Computed | Clear Guide Optical Head | |
| 14 | B201CGOH0 | CGOH | CG-OH | The device is intended as an accessory hardware to provide input into medical de The device is intended as an accessory hardware to provide input into medical device software by capturing video and other sensory information from the operational field for purposes of future processing. The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | Clear Guide Optical Head |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00815871020466 | 60138ND | FS-60 Advance | AVANTE | ||
| 2 | 00815871020459 | 60138N | FS-60 Advance | AVANTE | ||
| 3 | 00815871020442 | 60138A | FS-60 Advance | AVANTE | ||
| 4 | 00815871020435 | 60138 | FS-32P | AVANTE | ||
| 5 | 00815871020329 | 60138U50E | Crystal 4P | AVANTE | ||
| 6 | 00815871020312 | 60138U50C | Crystal 4P | AVANTE | ||
| 7 | 00815871020305 | 60138U50 | Crystal 4P | AVANTE | ||
| 8 | 00812559011228 | 16040 | Handheld, battery-powered, ultrasound device intended to measure the thicknes Handheld, battery-powered, ultrasound device intended to measure the thickness of the cornea. The device tip is touched to a patient's eye during the measurement. | iPac® Pachymeter | REICHERT, INC. | |
| 9 | 00801741225895 | SR8v3.0.1 | SR8v3.0.1 | Site~Rite 8 Software v. 3.0.1 | Site~Rite 8 Ultrasound System | BARD ACCESS SYSTEMS, INC. |
| 10 | 00801741222566 | 9770705 | 9770705 | BD Prevue II Magnetizer Cover | BD Prevue II Peripheral Vascular Access System | BARD ACCESS SYSTEMS, INC. |
| 11 | 00801741219382 | SR8v2.3.1 | SR8v2.3.1 | Site~Rite 8 Software v. 2.3.1 | Site~Rite 8 Ultrasound System | BARD ACCESS SYSTEMS, INC. |
| 12 | 00801741219344 | SR8v2.2.0 | SR8v2.2.0 | Site~Rite 8 Host System Software | Site~Rite 8 | BARD ACCESS SYSTEMS, INC. |
| 13 | 00801741219252 | SR8 USv2.2.0 | SR8 USv2.2.0 | Site~Rite 8 Ultrasound Application Software | Site~Rite 8 | BARD ACCESS SYSTEMS, INC. |
| 14 | 00801741215049 | 9770715 | 9770715 | BD Prevue II Battery | BD Prevue II Peripheral Vascular Access System | BARD ACCESS SYSTEMS, INC. |
| 15 | 00801741215032 | 9770713 | 9770713 | BD Prevue II Power Supply | BD Prevue II Peripheral Vascular Access System | BARD ACCESS SYSTEMS, INC. |
| 16 | 00801741215025 | 9770712 | 9770712 | BD Prevue II Cord Wrap | BD Prevue II Peripheral Vascular Access System | BARD ACCESS SYSTEMS, INC. |
| 17 | 00801741215018 | 9770711 | 9770711 | BD Prevue II Cue Magnetizer | BD Prevue II Peripheral Vascular Access System | BARD ACCESS SYSTEMS, INC. |
| 18 | 00801741215001 | 9770710 | 9770710 | BD Prevue II Probe Holder | BD Prevue II Peripheral Vascular Access System | BARD ACCESS SYSTEMS, INC. |
| 19 | 00801741214998 | 9770709 | 9770709 | BD Prevue II Roll Stand | BD Prevue II Peripheral Vascular Access System | BARD ACCESS SYSTEMS, INC. |
| 20 | 00801741214981 | 9770704R | 9770704R | BD Prevue II Vascular Access Probe (Refurbished) | BD Prevue II Peripheral Vascular Access System | BARD ACCESS SYSTEMS, INC. |
| 21 | 00801741214974 | 9770704 | 9770704 | BD Prevue II Vascular Access Probe | BD Prevue II Peripheral Vascular Access System | BARD ACCESS SYSTEMS, INC. |
| 22 | 00801741214967 | 9770703R | 9770703R | BD Prevue II Traditional Probe (Refurbished) | BD Prevue II Peripheral Vascular Access System | BARD ACCESS SYSTEMS, INC. |
| 23 | 00801741214950 | 9770703 | 9770703 | BD Prevue II Traditional Probe | BD Prevue II Peripheral Vascular Access System | BARD ACCESS SYSTEMS, INC. |
| 24 | 00801741214929 | 9770700R | 9770700R | BD Prevue II Console (Refurbished) | BD Prevue II Peripheral Vascular Access System | BARD ACCESS SYSTEMS, INC. |
| 25 | 00801741214912 | 9770700 | 9770700 | BD Prevue II Console | BD Prevue II Peripheral Vascular Access System | BARD ACCESS SYSTEMS, INC. |
| 26 | 00801741184215 | SR8v2.0.3 | SR8v2.0.3 | Site~Rite 8 Application Host | Site~Rite 8 | BARD ACCESS SYSTEMS, INC. |
| 27 | 00801741184208 | SR8v2.0.2 | SR8v2.0.2 | Site~Rite 8 Ultrasound System Application Host Software Version 2.0.2 | Site~Rite 8 | BARD ACCESS SYSTEMS, INC. |
| 28 | 00801741161094 | SR8 USv2.1.0 | SR8 USv2.1.0 | Site~Rite 8 Ultrasound System Host Software | Site~Rite 8 | BARD ACCESS SYSTEMS, INC. |
| 29 | 00801741161070 | SR8 USv2.0.1 | SR8 USv2.0.1 | SR8 USv2.0.1 | Site~Rite 8 Ultrasound System | BARD ACCESS SYSTEMS, INC. |
| 30 | 00801741155406 | 9770607 | 9770607 | Cue Upgrade Kit (Probe, Activator, Mnt arm) | Site~Rite 8 Ultrasound System | BARD ACCESS SYSTEMS, INC. |
| 31 | 00801741155390 | 9770606 | 9770606 | Cue Start Kit (SR8, Probe, Activator, Mnt arm) | Site~Rite 8 Ultrasound System | BARD ACCESS SYSTEMS, INC. |
| 32 | 00801741143816 | Site~Rite 8 Version 2.1.0 | Site~Rite 8 Version 2.1.0 | Site~Rite 8 Ultrasound System | Site~Rite 8 | BARD ACCESS SYSTEMS, INC. |
| 33 | 00801741143809 | Site~Rite 8 Version 2.0.1 | Site~Rite 8 Version 2.0.1 | Site~Rite 8 Version 2.0.1 | Site~Rite 8 Ultrasound System | BARD ACCESS SYSTEMS, INC. |
| 34 | 00801741138287 | 9770600Y | 9770600Y | Site~Rite 8 Ultrasound System Console (Remanufactured) | Site~Rite 8 Ultrasound System | BARD ACCESS SYSTEMS, INC. |
| 35 | 00801741138270 | 9770600X | 9770600X | Site~Rite 8 Ultrasound System Console (Refurbished) | Site~Rite 8 Ultrasound System | BARD ACCESS SYSTEMS, INC. |
| 36 | 00801741138263 | 9770600 | 9770600 | Site~Rite 8 Ultrasound System Console | Site~Rite 8 Ultrasound System | BARD ACCESS SYSTEMS, INC. |
| 37 | 00801741138256 | 9770605 | 9770605 | Cue Mounting Arm | Site~Rite 8 Ultrasound System | BARD ACCESS SYSTEMS, INC. |
| 38 | 00801741138232 | 9770604 | 9770604 | Cue Activator | Site~Rite 8 Ultrasound System | BARD ACCESS SYSTEMS, INC. |
| 39 | 00801741125782 | 9760035 | 9760035 | SITE-RITE 5 EXTERNAL BATTERY PACK | Site-Rite | BARD ACCESS SYSTEMS, INC. |
| 40 | 00801741125713 | 9770065 | 9770065 | SITE-RITE 5-EX BASE BATTERY UNIT | Site-Rite | BARD ACCESS SYSTEMS, INC. |
| 41 | 00801741125676 | 9770289 | 9770289 | ¼-20 Roll stand | Rollstand | BARD ACCESS SYSTEMS, INC. |
| 42 | 00801741125379 | 9770251R | 9770251R | REFURB, SR VISION II BASE | Site-Rite | BARD ACCESS SYSTEMS, INC. |
| 43 | 00801741125362 | 9770177R | 9770177R | REFURB, SR VISION II TOWER | Site-Rite | BARD ACCESS SYSTEMS, INC. |
| 44 | 00801741125355 | 9770176R | 9770176R | REFURB, SR VISION II DISPLAY | Site-Rite | BARD ACCESS SYSTEMS, INC. |
| 45 | 00801741124945 | 9770086R | 9770086R | REFURB, SR PREVUE PLUS ULTRASOUND SYSTEM | Site-Rite | BARD ACCESS SYSTEMS, INC. |
| 46 | 00801741124938 | 9770090R | 9770090R | REFURB, SITE-RITE PREVUE ULTRASOUND SYSTEM | Site-Rite | BARD ACCESS SYSTEMS, INC. |
| 47 | 00801741124747 | 9770031 | 9770031 | STANDARD ROLL STAND | Rollstand | BARD ACCESS SYSTEMS, INC. |
| 48 | 00801741124730 | 9770010 | 9770010 | PORTABLE ROLL STAND | Rollstand | BARD ACCESS SYSTEMS, INC. |
| 49 | 00801741124723 | 9770061 | 9770061 | SITE-RITE 5 GCX STANDARD ROLL STAND | Rollstand | BARD ACCESS SYSTEMS, INC. |
| 50 | 00801741124693 | 9770116 | 9770116 | BAS MEDICAL EQUIPMENT ROLL STAND (MER) | Rollstand | BARD ACCESS SYSTEMS, INC. |