LARYNGOTEC

Basic Information

• Brand Name: LARYNGOTEC
• Primary DI: 04051948021035
• Version / Model: 15955-11
• Company Name: Andreas Fahl Medizintechnik-Vertrieb GmbH
• Labeler DUNS: 314768383
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-17
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 0ebd5811-8615-4a1b-ace2-d4b508a726eb
• Distribution End Date: 2016-08-16

Device Description

LARYNGOTEC KOMBI Stoma Button, SIZE 11

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: No
• MRI Safety: MR Safe
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	868.5800	2
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	868.5730	2
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	868.5800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
14093	Tracheostoma button	A hollow device intended to be used routinely by a patient to prevent the narrowing of a tracheostoma during intermittent use of their tracheostomy or laryngectomy tube. It is a cylindrical synthetic polymer device designed for minimal intrusion beyond the tracheostomal orifice into which it is placed. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04051948021035	GS1

Customer Contacts

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