| Primary Device ID | B6143103011 |
| NIH Device Record Key | 7b5e1ef6-5230-4086-b2f0-c85ecbb77427 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AquaBeam Handpiece |
| Version Model Number | HP2000 |
| Catalog Number | HP2000 |
| Company DUNS | 016646472 |
| Company Name | PROCEPT BIOROBOTICS CORPORATION |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
| 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 |
| 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 |
|---|---|
| HIBCC | B6143103011 [Primary] |
| HIBCC | B614HP20001 [Primary] |
| PZP | Fluid jet removal system |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[B6143103011]
Ethylene Oxide
[B6143103011]
Ethylene Oxide
[B6143103011]
Ethylene Oxide
[B6143103011]
Ethylene Oxide
[B6143103011]
Ethylene Oxide
[B6143103011]
Ethylene Oxide
[B6143103011]
Ethylene Oxide
[B6143103011]
Ethylene Oxide
[B6143103011]
Ethylene Oxide
[B6143103011]
Ethylene Oxide
[B6143103011]
Ethylene Oxide
[B6143103011]
Ethylene Oxide
[B6143103011]
Ethylene Oxide
[B6143103011]
Ethylene Oxide
[B6143103011]
Ethylene Oxide
[B6143103011]
Ethylene Oxide
[B6143103011]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-04-05 |
| Device Publish Date | 2019-03-28 |
| B6143103011 | HP2000 |
| B614HP20001 | HP2000 |
| 00850055427006 | HP2000 |
| 00850055427037 | HP2000 |