GUDID 00385640026727

SUMMIT MEDICAL, INC.

Tympanostomy tube

• Primary Device ID: 00385640026727
• NIH Device Record Key: 41d251bb-8700-40fb-b279-88b6612cb6de
• Commercial Distribution Discontinuation: 2020-05-05
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: VT-0403-01-P
• 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	00385640026727 [Primary]

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: 4
• Public Version Date: 2020-05-06
• Device Publish Date: 2017-01-26

Devices Manufactured by SUMMIT MEDICAL, INC.

• 00385640088510 - INSTRUSAFE: 2025-10-03
• 00385640088503 - INSTRUSAFE: 2025-10-01
• 00385640088480 - INSTRUSAFE: 2025-09-30
• 00385640088497 - INSTRUSAFE: 2025-09-30
• 00385640088466 - INSTRUSAFE: 2025-09-29
• 00385640088473 - INSTRUSAFE: 2025-09-29
• 00385640088398 - INSTRUSAFE: 2025-09-26
• 00385640088404 - INSTRUSAFE: 2025-09-26