| Primary Device ID | 07290103421328 |
| NIH Device Record Key | 4fc04133-2a6a-4075-b535-a5c6b7670e7f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PainShield Plus Actuator |
| Version Model Number | 3.0 |
| Catalog Number | 10-600-0007 |
| Company DUNS | 080326793 |
| Company Name | NANOVIBRONIX INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| 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 |
| Phone | 914-233-3004 |
| info@nanovibronix.com | |
| Phone | 914-233-3004 |
| info@nanovibronix.com | |
| Phone | 914-233-3004 |
| info@nanovibronix.com | |
| Phone | 914-233-3004 |
| info@nanovibronix.com | |
| Phone | 914-233-3004 |
| info@nanovibronix.com | |
| Phone | 914-233-3004 |
| info@nanovibronix.com | |
| Phone | 914-233-3004 |
| info@nanovibronix.com | |
| Phone | 914-233-3004 |
| info@nanovibronix.com | |
| Phone | 914-233-3004 |
| info@nanovibronix.com | |
| Phone | 914-233-3004 |
| info@nanovibronix.com | |
| Phone | 914-233-3004 |
| info@nanovibronix.com | |
| Phone | 914-233-3004 |
| info@nanovibronix.com | |
| Phone | 914-233-3004 |
| info@nanovibronix.com | |
| Phone | 914-233-3004 |
| info@nanovibronix.com | |
| Phone | 914-233-3004 |
| info@nanovibronix.com | |
| Phone | 914-233-3004 |
| info@nanovibronix.com | |
| Phone | 914-233-3004 |
| info@nanovibronix.com |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290103421328 [Primary] |
| PFW | Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-24 |
| Device Publish Date | 2023-07-16 |
| 07290103420277 - UroShield 3.0 Driver | 2023-08-02 The UroShield driver is an electronic unit intended to drive an accessory (Ultrasonic Actuator) that creates surface acoustic wa |
| 07290103422011 - PainShield Patch | 2023-08-01 PainShield patch is a component of the PainShield MD system. |
| 07290103421144 - PainShield 3.0 Actuator | 2023-07-24 PainShield actuator is part of the PainShield MD System. |
| 07290103421328 - PainShield Plus Actuator | 2023-07-24PainShield Plus Actuator is part of the PainShield Plus system. |
| 07290103421328 - PainShield Plus Actuator | 2023-07-24 PainShield Plus Actuator is part of the PainShield Plus system. |
| 07290103422028 - PainShield 3.0 Driver | 2023-07-24 PainShield MD applies ultrasound energy through a treatment patch that is placed at, or close to, the center of the painful area |
| 07290103422035 - PainShield Plus 3.0 Driver | 2023-07-24 PainShield MD Plus is intended to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selecte |
| 07290103421014 - PainShield | 2022-11-14 PainShield MD applies ultrasound energy through a treatment patch that is placed at, or close to, the center of the painful area |
| 07290103421267 - PainShield MD Plus Monnthly kit | 2022-05-24 The Monthly kit includes a treatment actuator that incorporates an ultrasonic transducer and connects to the driver with a cable |