Solo+ TTD Handpiece

Basic Information

• Brand Name: Solo+ TTD Handpiece
• Primary DI: 05391528890156
• Version / Model: 12115-100-000
• Catalog Number: 12115-100-000
• Company Name: AVENTAMED DESIGNATED ACTIVITY COMPANY
• Labeler DUNS: 985579745
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-19
• Public Version: 1
• Public Version Date: 2024-07-29
• Public Version Status: New
• Public Device Record Key: 1a398e57-7252-4f07-b6e4-9da16f7f59d5

Device Description

The Solo+ TTD is a single use, sterile, “all-in-one” surgical instrument that rapidly places a tympanostomy tube across the tympanic membrane of a patient. It combines the traditionally separate functions of creating a myringotomy, and positioning and placing a tympanostomy tube across the tympanic membrane. Placement of the tube provides ventilation to the middle ear space through the tympanic membrane.

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: 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
ETD	Tube, Tympanostomy	Ear, Nose, Throat	874.3880	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33794	Tympanostomy tube	A small, hollow cylinder intended to be implanted, by insertion through the tympanic membrane, for ventilation or drainage of the middle ear. Otherwise known as a myringotomy tube, grommet or an aural vent tube, it is made of materials such as polytetrafluoroethylene (PTFE), polyethylene (PE), silicon elastomer, or porous polyethylene. One type, known as the malleus clip tube, attaches to the malleus. Disposable devices associated with implantation may be included with the device, which may be used to implant bilateral tubes.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05391528890163	GS1	Carton Box	4	In Commercial Distribution
Primary	05391528890156	GS1
Package	05391528890170	GS1	Case	9	In Commercial Distribution
Package	05391528890187	GS1	Case	6	In Commercial Distribution
Package	05391528890194	GS1	Case	3	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K232702	000