n.a.

Basic Information

• Brand Name: n.a.
• Primary DI: 04048551051764
• Version / Model: 11577BP
• Company Name: Karl Storz GmbH & Co. KG
• Labeler DUNS: 315731430
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2019-02-23
• Public Version: 1
• Public Version Date: 2019-03-11
• Public Version Status: New
• Public Device Record Key: 09a19afe-4e55-4c8e-aaf8-6074f42d5ddd

Device Description

Balloon Catheter, 0.9 mm

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GBA	CATHETER, BALLOON TYPE	General, Plastic Surgery	878.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60446	Salivary gland balloon catheter	A sterile, flexible tube with a distensible balloon(s) at its distal tip designed to be used for the dilation of a lesion and/or stricture of the salivary ducts. It is typically inserted into a salivary duct and advanced to the stenotic site where it is inflated under endoscopic, fluoroscopic or ultrasonic control; it may be used with a guidewire. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04048551051764	GS1
Unit of Use	04048551261903	GS1