GUDID 00385640002363

SUMMIT MEDICAL, INC.

Tympanostomy tube

• Primary Device ID: 00385640002363
• NIH Device Record Key: 18f1a2b9-bb04-4ca7-a406-c13505ee6d5f
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: VT-1601-01
• 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	00385640002363 [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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

Devices Manufactured by SUMMIT MEDICAL, INC.

• 00385640086349 - INSTRUSAFE: 2025-04-21
• 00385640086356 - INSTRUSAFE: 2025-04-21
• 00385640086363 - INSTRUSAFE: 2025-04-21
• 00385640086370 - INSTRUSAFE: 2025-04-21
• 00385640086387 - INSTRUSAFE: 2025-04-21
• 00385640086318 - INSTRUSAFE: 2025-04-18
• 00385640086325 - INSTRUSAFE: 2025-04-18
• 00385640086332 - INSTRUSAFE: 2025-04-18