| Primary Device ID | 00850055427068 |
| NIH Device Record Key | deaec4ce-7c1c-4a7d-83e4-dc843235d33f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HYDROS Robotic System |
| Version Model Number | HY1000 |
| Company DUNS | 016646472 |
| Company Name | PROCEPT BIOROBOTICS CORPORATION |
| 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 | 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 | false |
| OTC Over-The-Counter | false |
| Phone | +1(650)232-7222 |
| customerservice@procept-biorobotics.com | |
| Phone | +1(650)232-7222 |
| customerservice@procept-biorobotics.com | |
| Phone | +1(650)232-7222 |
| customerservice@procept-biorobotics.com | |
| Phone | +1(650)232-7222 |
| customerservice@procept-biorobotics.com | |
| Phone | +1(650)232-7222 |
| customerservice@procept-biorobotics.com | |
| Phone | +1(650)232-7222 |
| customerservice@procept-biorobotics.com | |
| Phone | +1(650)232-7222 |
| customerservice@procept-biorobotics.com | |
| Phone | +1(650)232-7222 |
| customerservice@procept-biorobotics.com | |
| Phone | +1(650)232-7222 |
| customerservice@procept-biorobotics.com | |
| Phone | +1(650)232-7222 |
| customerservice@procept-biorobotics.com | |
| Phone | +1(650)232-7222 |
| customerservice@procept-biorobotics.com | |
| Phone | +1(650)232-7222 |
| customerservice@procept-biorobotics.com | |
| Phone | +1(650)232-7222 |
| customerservice@procept-biorobotics.com | |
| Phone | +1(650)232-7222 |
| customerservice@procept-biorobotics.com |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850055427068 [Primary] |
| PZP | Fluid jet removal system |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-09-16 |
| Device Publish Date | 2024-09-06 |
| 00850055427051 - HYDROS Handpiece | 2024-09-16 |
| 00850055427068 - HYDROS Robotic System | 2024-09-16 |
| 00850055427068 - HYDROS Robotic System | 2024-09-16 |
| 00850055427075 - HYDROS TRUS Probe | 2024-09-16 |
| 00850055427037 - AquaBeam Handpiece | 2023-12-25 |
| 00850055427044 - Lithotomy Drape | 2023-12-25 |
| 00850055427006 - AquaBeam Handpiece | 2023-09-04 |
| 00850055427013 - AquaBeam Scope | 2023-09-04 |
| 00850055427020 - AquaBeam Robotic System | 2023-09-04 |