NA

Basic Information

• Brand Name: NA
• Primary DI: 10886982129574
• Version / Model: 05.001.184
• Catalog Number: 05001184
• Company Name: Synthes GmbH
• Labeler DUNS: 486711679
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-30
• Public Version: 5
• Public Version Date: 2022-04-18
• Public Version Status: Update
• Public Device Record Key: 1638f84b-5ea5-4f5f-93ab-0358c6a47e80

Device Description

IRRIGATION NOZZLE FOR EPD AND APD FOR USE WITH 05.001.182

Device Characteristics

• Single Use: No
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HBB	MOTOR, DRILL, PNEUMATIC	Neurology	882.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47886	Surgical power tool irrigation-control device	A device designed to be activated by the surgeon to regulate the flow of irrigation fluid (normally sterile saline) to the surgical site where a rotational high-speed cutting tool [e.g., 40.000 - 90.000 revolutions per minute (rpm)] is being applied to bone; primarily to provide the fluid as a coolant to the cutting tool (e.g., a bur or drill bit) and the site to avoid necrosis. It typically consists of tubing, connectors, and a simple electrically or pneumatically activated valve in which the coolant tubing is placed and which is pinched to regulate the fluid flow. It is typically made of metal and/or synthetic materials. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	07611819414785	GS1
Secondary	H679050011840	HIBCC
Primary	10886982129574	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K093361	000