GUDID 00385640061933

SUMMIT MEDICAL, INC.

Tympanostomy tube

• Primary Device ID: 00385640061933
• NIH Device Record Key: ea277fc9-3063-45a4-81d6-3a7b007ada3c
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: ET-SGDT-45T
• Company DUNS: 965484699
• Company Name: SUMMIT MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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	00385640061933 [Primary]
GS1	10385640061930 [Package]; 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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-01-22
• Device Publish Date: 2020-11-10

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