Provox Dilator

Basic Information

• Brand Name: Provox Dilator
• Primary DI: 07331791181207
• Version / Model: 8341
• Catalog Number: 8341
• Company Name: Atos Medical AB
• Labeler DUNS: 355470923
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2025-02-08
• Public Version: 1
• Public Version Date: 2025-02-17
• Public Version Status: New
• Public Device Record Key: b147abbc-bbe7-4246-a2e7-54e2566d1228

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: Yes
• 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
LRC	INSTRUMENT, ENT MANUAL SURGICAL	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
67401	Tracheoesophageal fistula dilator, single-use	A hand-held, manual non-surgical instrument intended to dilate a surgically-created tracheoesophageal fistula (puncture) to facilitate insertion of a tracheoesophageal device (typically a non-indwelling tracheoesophageal speech valve); it may in addition be used as a temporary occluder to prevent leakage of fluids from the oesophagus into the trachea. It is a flexible, tapered, synthetic polymer shaft with a handle designed to access the fistula via the tracheostoma. It is intended for transient-use by the patient or clinician, in the home and healthcare facility. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	07331791181191	GS1
Primary	07331791181207	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from rain. Keep away from sunlight.