Epistax Balloon Catheter

Basic Information

• Brand Name: Epistax Balloon Catheter
• Primary DI: 00385640000246
• Version / Model: RC-4200
• Catalog Number: RC-4200
• Company Name: Summit Medical, Inc.
• Labeler DUNS: 965484699
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-09
• Public Version: 6
• Public Version Date: 2021-08-23
• Public Version Status: Update
• Public Device Record Key: 54fdc989-8a5e-46c3-96d8-fd9b474ac58f
• Distribution End Date: 2021-01-07

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: Yes
• 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
EMX	Balloon, Epistaxis	Ear, Nose, Throat	874.4100	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12699	Nasal haemostatic balloon	A device consisting of a hollow rubber or rubber-like structure, expandable with either liquid or air, intended to be used to control nose bleeding (epistaxis) of the anterior or posterior nasal cavity. It is applied during an ear/nose/throat (ENT) intervention and can also be used to treat glue ear in children, and/or to support the structure and patency of the nasal canal. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00385640000246	GS1

Customer Contacts

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