XprESS Ultra

Basic Information

• Brand Name: XprESS Ultra
• Primary DI: 00857326005116
• Version / Model: MSB&LLF
• Catalog Number: ULF-105
• Company Name: ENTELLUS MEDICAL, INC.
• Labeler DUNS: 017283879
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-11-27
• Public Version: 7
• Public Version Date: 2023-07-07
• Public Version Status: Update
• Public Device Record Key: be2e1740-12d0-4a57-a4e9-95a7baef6280

Device Description

ENT Dilation System 5x20mm

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
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	874.4420	1
PNZ	Eustachian Tube Balloon Dilation Device	Ear, Nose, Throat	874.4180	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48140	Nasal/paranasal balloon catheter	A sterile flexible tube with an inflatable balloon at its distal tip designed to gently restructure nasal passages and dilate obstructed sinus ostia during a surgical procedure (sinuplasty), typically to treat sinusitis, and/or to gently restructure nasal passages to temporarily relieve nasal obstruction/congestion. The device typically consists of a single-lumen tube with a connector at the proximal end for attachment to an inflation device. This is a single-use device.	No	Active
10718	Eustachian catheter, single-use	A long, flexible tube used for middle ear drainage and/or temporary equalization of the pressure on both sides of the eardrum via insufflation. The distal tip is passed along the floor of the nose and guided into the Eustachian tube; air may be blown through the device and into the middle ear. It is typically made of plastic. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00857326005116	GS1
Package	10857326005113	GS1	Shelf Box	1	In Commercial Distribution