FDA UDI
In Commercial Distribution
🇺🇸 United States
AquaBeam Handpiece
DI: B614HP20001
·
Model: HP2000
·
PROCEPT BioRobotics Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- AquaBeam Handpiece
- Primary DI
- B614HP20001
- Version / Model
- HP2000
- Catalog Number
- HP2000
- Company Name
- PROCEPT BioRobotics Corporation
- Labeler DUNS
- 016646472
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-03-28
- Public Version
- 3
- Public Version Date
- 2026-01-19
- Public Version Status
- Update
- Public Device Record Key
- 7b5e1ef6-5230-4086-b2f0-c85ecbb77427
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PZP | Fluid jet removal system | General, Plastic Surgery | 876.4350 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47559 | Water jet knife system handpiece, single-use | A sterile, hand-operated device that is a component of a water jet knife system and designed to direct a concentrated stream of high-pressure water (typically sterile saline) to a surgical site to cut/dissect tissue. This handpiece is connected to a generator that pressurizes the water; it may also facilitate the aspiration of fluid and debris from the surgical site. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Previous | B6143103011 | HIBCC | ||||
| Primary | B614HP20001 | HIBCC |
Customer Contacts
- Phone
- +1(650)232-7222
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN170024 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -18 – 60 Degrees Celsius