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
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