N/A

Basic Information

• Brand Name: N/A
• Primary DI: 20681490195571
• Version / Model: 9128000
• Company Name: MEDTRONIC XOMED, INC.
• Labeler DUNS: 835465063
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2017-09-09
• Public Version: 5
• Public Version Date: 2021-03-11
• Public Version Status: Update
• Public Device Record Key: 03be8e80-5f16-4af9-a19e-0663e04b1ec0

Device Description

CATHETER 9128000 10PK MALL SINUS IRRIG

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GBX	CATHETER, IRRIGATION	General, Plastic Surgery	878.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
18716	Nasal haemostatic catheter	A tubular device intended to be inserted into the nose to control nose bleeding (epistaxis) by direct pressure. It is typically a single-lumen tube with a sponge attached near its distal tip, and may include an integral airway that allows the patient to breathe through the nose while the catheter is in place. Some designs consist of a double-lumen with a balloon attached to each distal end to be used simultaneously in both nasal cavities and can also be used to stabilize zygomatic arch fractures. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20681490195571	GS1
Unit of Use	00681490195577	GS1

Customer Contacts

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