FDA UDI
In Commercial Distribution
🇺🇸 United States
AquaBeam Robotic System
DI: B614AB20001
·
Model: AB2000
·
PROCEPT BioRobotics Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- AquaBeam Robotic System
- Primary DI
- B614AB20001
- Version / Model
- AB2000
- Catalog Number
- AB2000
- 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
- 794eb9c8-728f-425b-9bca-b8932c85f7f4
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
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 |
|---|---|---|---|---|
| 45396 | Water jet knife system | An assembly of devices designed to surgically cut/dissect soft body tissues using a stream of high pressure water, leaving hard/elastic structures (e.g., bone, ligaments) intact. It includes a mains electricity (AC-powered) generator to create the hydraulic pressure, tubing, and a handpiece to direct and apply the cutting stream of water; this is typically sterile saline. It may also assist in the irrigation of the surgical site to help improve site visibility. The system is commonly used to remove burned/damaged skin, tumours, and varicose veins; it may be used endoscopically. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Previous | B6142101011 | HIBCC | ||||
| Primary | B614AB20001 | 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