Device
The Perilav Jet Lavage System is intended for debridement of subdermal wounds. The Pump is a component of this System.
Manufacturer
Stiehl Tech, LLC
Stiehl Tech, LLC
Model: Pump
Catalog: PL3001
DI: B674PL30010
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-13
Current Version: 2026-05-21
Description
The Perilav Jet Lavage System is intended for debridement of subdermal wounds. The Pump is a component of this System.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
fd5d03c7-b460-47f5-8460-aa00a7d8de7c
Distribution Status:
In Commercial Distribution
DUNS Number:
081177942
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
B674PL30010
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 33579
Name: Surgical irrigation/aspiration pump, reusable
Definition:
An electrically-powered device, which may include noninvasive accessories, intended to both irrigate and aspirate (i.e., capable of both functions) body cavities and wounds typically during an endoscopic and/or orthopaedic surgical procedure, usually to facilitate observation. It is intended to remove tissues/fluids/debris through suction, and to irrigate the surgical site with a sterile fluid (e.g., saline); it is not intended to administer parenteral fluids or drugs. The device may include collection containers or tubing; it does not include patient contact devices (e.g., handpiece/tip, catheter). This is a reusable device.
FDA Product Codes
FQH
Lavage, Jet
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value:
-30
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