GUDID 00385640001106

SUMMIT MEDICAL, INC.

Tympanostomy tube

• Primary Device ID: 00385640001106
• NIH Device Record Key: 7cb0192b-b2a1-42dd-ad86-5799b8436063
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: VT-0403-01
• 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	00385640001106 [Primary]
GS1	10385640001103 [Package]; Package: Box [6 Units]; In Commercial Distribution
GS1	20385640001100 [Package]; Package: Box [50 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: 4
• Public Version Date: 2020-05-06
• Device Publish Date: 2016-09-12

Devices Manufactured by SUMMIT MEDICAL, INC.

• 00385640085724 - INSTRUSAFE: 2025-03-12
• 00385640085731 - INSTRUSAFE: 2025-03-12
• 00385640085649 - INSTRUSAFE: 2025-03-11
• 00385640085656 - INSTRUSAFE: 2025-03-11
• 00385640085663 - INSTRUSAFE: 2025-03-11
• 00385640085670 - INSTRUSAFE: 2025-03-11
• 00385640085687 - INSTRUSAFE: 2025-03-11
• 00385640085694 - INSTRUSAFE: 2025-03-11