AccessGUDID - DEVICE: AquaBeam Robotic System (B614AB20001)

GUDID

Device Identifier (DI) Information

Brand Name: AquaBeam Robotic System
Version or Model: AB2000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AB2000
Company Name: PROCEPT BioRobotics Corporation

Primary DI Number: B614AB20001
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 016646472 *Terms of Use
Previous DI: B6142101011

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PZP	Fluid jet removal system

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN170024	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -18 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 794eb9c8-728f-425b-9bca-b8932c85f7f4
Public Version Date: January 19, 2026
Public Version Number: 3
DI Record Publish Date: March 28, 2019