Solo+ TTD Handpiece 12115-100-000

GUDID 05391528890163

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.

AVENTAMED DESIGNATED ACTIVITY COMPANY

Tympanostomy tube

• Primary Device ID: 05391528890163
• NIH Device Record Key: 1a398e57-7252-4f07-b6e4-9da16f7f59d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solo+ TTD Handpiece
• Version Model Number: 12115-100-000
• Catalog Number: 12115-100-000
• Company DUNS: 985579745
• Company Name: AVENTAMED DESIGNATED ACTIVITY COMPANY
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +353214928980
• Email: john.vaughan@karlstorz.com
• Phone: +353214928980
• Email: john.vaughan@karlstorz.com
• Phone: +353214928980
• Email: john.vaughan@karlstorz.com
• Phone: +353214928980
• Email: john.vaughan@karlstorz.com
• Phone: +353214928980
• Email: john.vaughan@karlstorz.com
• Phone: +353214928980
• Email: john.vaughan@karlstorz.com
• Phone: +353214928980
• Email: john.vaughan@karlstorz.com
• Phone: +353214928980
• Email: john.vaughan@karlstorz.com
• Phone: +353214928980
• Email: john.vaughan@karlstorz.com
• Phone: +353214928980
• Email: john.vaughan@karlstorz.com
• Phone: +353214928980
• Email: john.vaughan@karlstorz.com
• Phone: +353214928980
• Email: john.vaughan@karlstorz.com
• Phone: +353214928980
• Email: john.vaughan@karlstorz.com
• Phone: +353214928980
• Email: john.vaughan@karlstorz.com
• Phone: +353214928980
• Email: john.vaughan@karlstorz.com
• Phone: +353214928980
• Email: john.vaughan@karlstorz.com
• Phone: +353214928980
• Email: john.vaughan@karlstorz.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391528890156 [Primary]
GS1	05391528890163 [Package]; Contains: 05391528890156; Package: Carton Box [4 Units]; In Commercial Distribution
GS1	05391528890170 [Package]; Package: Case [9 Units]; In Commercial Distribution
GS1	05391528890187 [Package]; Package: Case [6 Units]; In Commercial Distribution
GS1	05391528890194 [Package]; Package: Case [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232702

FDA Product Code

• ETD: Tube, Tympanostomy

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-29
• Device Publish Date: 2024-07-19

Devices Manufactured by AVENTAMED DESIGNATED ACTIVITY COMPANY

• 05391528890101 - Solo+ TTD Cartridge: 2024-07-29 The Solo+ TTD is a single use, sterile, “all-in-one” surgical instrument that rapidly places a tympanostomy tube across the
• 05391528890163 - Solo+ TTD Handpiece: 2024-07-29The 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.
• 05391528890163 - Solo+ TTD Handpiece: 2024-07-29 The Solo+ TTD is a single use, sterile, “all-in-one” surgical instrument that rapidly places a tympanostomy tube across the