Ponto

Basic Information

• Brand Name: Ponto
• Primary DI: 05712149026302
• Version / Model: 220701
• Catalog Number: 220701
• Company Name: Oticon Medical AB
• Labeler DUNS: 554563994
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-31
• Public Version: 2
• Public Version Date: 2022-12-05
• Public Version Status: Update
• Public Device Record Key: 99b2a37e-4400-438c-a346-3d5542d11992

Device Description

MONO Surgery Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
MAH	Hearing Aid, Bone Conduction, Implanted	Ear, Nose, Throat	874.3302	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44069	ENT surgical procedure kit, non-medicated, single-use	A collection of various sterile ear/nose/throat (ENT) surgical instruments, dressings and the necessary materials used to perform an ENT surgical procedure. It does not contain pharmaceuticals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05712149026302	GS1

Customer Contacts

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