GUDID 10385640023679

Summit Medical, Inc.

Tympanostomy tube

• Primary Device ID: 10385640023679
• NIH Device Record Key: ae80a9bb-3804-4d07-b818-852615fbd8d9
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: ET-AGDT-40
• Company DUNS: 965484699
• Company Name: Summit Medical, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00385640023672 [Primary]
GS1	10385640023679 [Package]; Contains: 00385640023672; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K830228

FDA Product Code

• ETD: Tube, Tympanostomy

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-08-23
• Device Publish Date: 2020-11-04

Devices Manufactured by Summit Medical, Inc.

• 00385640089272 - INSTRUSAFE: 2025-11-28
• 00385640089234 - INSTRUSAFE: 2025-11-26
• 00385640089241 - INSTRUSAFE: 2025-11-26
• 00385640089258 - INSTRUSAFE: 2025-11-26
• 00385640089265 - INSTRUSAFE: 2025-11-26
• 00385640089227 - INSTRUSAFE: 2025-11-25
• 00385640089203 - INSTRUSAFE: 2025-11-24
• 00385640089210 - INSTRUSAFE: 2025-11-24