SurgiLav

Basic Information

• Brand Name: SurgiLav
• Primary DI: 04546540860637
• Version / Model: 0207580000
• Catalog Number: 0207580000
• Company Name: STRYKER CORPORATION
• Labeler DUNS: 196548481
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 4
• Public Version Date: 2020-11-06
• Public Version Status: Update
• Public Device Record Key: 984db731-f1cf-4707-97a7-be9f82e8ac11

Device Description

Plus Handpiece with Suction Tubing

Device Characteristics

• Single Use: Yes
• 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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FQH	LAVAGE, JET	General Hospital	880.5475	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47890	Disposable surgical irrigation/aspiration system	A device assembly designed to irrigate, wash, and evacuate debris from general soft-tissue and orthopaedic surgical sites (e.g., for soft-tissue wound or bone debridement, site clearing, bone cement residue removal) with a pulsatile jet of sterile fluid (typically saline). It typically consists of a handpiece with an electrically-powered pump and irrigation/suction controls, tubing, and patient contact devices [typically detachable tips (applicators)] of various shapes and sizes for specific surgical applications. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	34546540860638	GS1	pack	6	In Commercial Distribution
Primary	04546540860637	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Length	10.0	Feet

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 75 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 40 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal