Epistaxis balloon catheter

Basic Information

• Brand Name: Epistaxis balloon catheter
• Primary DI: 04711182605483
• Version / Model: 3103-0930
• Catalog Number: 3103-0930
• Company Name: Spiggle & Theis Medizintechnik GmbH
• Labeler DUNS: 332893028
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-23
• Public Version: 1
• Public Version Date: 2025-06-02
• Public Version Status: New
• Public Device Record Key: e31f2aaa-7217-4831-87b2-4f5e259a0011

Device Description

silicone sterile, 1 piece/box

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: 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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• 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
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	04711182605483	GS1

Customer Contacts

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