GUDID 10385640023655

SUMMIT MEDICAL, INC.

Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube

• Primary Device ID: 10385640023655
• NIH Device Record Key: dc25c620-9436-42d1-bdfd-acc86a6e95b7
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: ET-ABDT-45-7
• 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	00385640023658 [Primary]
GS1	10385640023655 [Package]; Contains: 00385640023658; 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-26
• Device Publish Date: 2021-05-18

Devices Manufactured by SUMMIT MEDICAL, INC.

• 00385640081030 - INSTRUSAFE: 2024-05-21
• 00385640081047 - INSTRUSAFE: 2024-05-21
• 00385640081023 - INSTRUSAFE: 2024-05-20
• 00385640081009 - INSTRUSAFE: 2024-05-15
• 00385640081016 - INSTRUSAFE: 2024-05-15
• 00385640080996 - INSTRUSAFE: 2024-05-14
• 00385640080972 - INSTRUSAFE: 2024-05-13
• 00385640080989 - INSTRUSAFE: 2024-05-13