Model: HP2000
Catalog: HP2000-E
DI: 00850055427129
Status: New
MRI: MR Unsafe
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-04-28
Current Version: 2026-05-06
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
de199b85-48cf-4d2b-9618-9065eeec924c
Distribution Status:
In Commercial Distribution
DUNS Number:
016646472
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00850055427129
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 47559
Name: Water jet knife system handpiece, single-use
Definition:
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.
FDA Product Codes
PZP
Fluid jet removal system
Premarket Submissions
Submission Number:
K241952
Supplement Number:
000
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value:
-18
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value:
60
Storage Handling - Storage Handling Type:
Storage Environment Temperature