GUDID 00385640026581

SUMMIT MEDICAL, INC.

Tympanostomy tube

• Primary Device ID: 00385640026581
• NIH Device Record Key: cc6a7b97-5dec-4df3-b0f8-b3e885bbb9e2
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: VT-0200-01-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: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00385640026581 [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: 2017-01-26

Devices Manufactured by SUMMIT MEDICAL, INC.

• 00385640083881 - INSTRUSAFE: 2024-11-19
• 00385640083898 - INSTRUSAFE: 2024-11-19
• 00385640083874 - INSTRUSAFE: 2024-11-18
• 00385640083836 - INSTRUSAFE: 2024-11-15
• 00385640083843 - INSTRUSAFE: 2024-11-15
• 00385640083850 - INSTRUSAFE: 2024-11-15
• 00385640083867 - INSTRUSAFE: 2024-11-15
• 00385640083805 - INSTRUSAFE: 2024-11-14