ULTREX

Basic Information

• Brand Name: ULTREX
• Primary DI: 00801741010316
• Version / Model: 0067720
• Catalog Number: 0067720
• Company Name: Davol Inc.
• Labeler DUNS: 001191048
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-12-22
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 51084d16-7c88-4ecf-a656-0ca0f4fbebf2

Device Description

ULTREX Retractable Splash Shield Tip

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: No
• 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
18033	Surgical mist irrigation tip	A device that is designed to deliver a combined stream of air and mist to clear blood from a specific area of a surgical site. This device is a special perforated tip which can be affixed to an appropriate kind of tubing that delivers the rinsing fluids. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10801741010313	GS1	CA	10	In Commercial Distribution
Primary	00801741010316	GS1

Customer Contacts

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