GUDID 00385640061568

T-TUBE INSERTER

SUMMIT MEDICAL, INC.

Tympanostomy tube

• Primary Device ID: 00385640061568
• NIH Device Record Key: f7a5d453-ae25-4015-a5bc-ff04b1531860
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: T-TUBE
• 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	00385640061568 [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

[00385640061568]

Moist Heat or Steam Sterilization

[00385640061568]

Moist Heat or Steam Sterilization

[00385640061568]

Moist Heat or Steam Sterilization

[00385640061568]

Moist Heat or Steam Sterilization

[00385640061568]

Moist Heat or Steam Sterilization

[00385640061568]

Moist Heat or Steam Sterilization

[00385640061568]

Moist Heat or Steam Sterilization

[00385640061568]

Moist Heat or Steam Sterilization

[00385640061568]

Moist Heat or Steam Sterilization

[00385640061568]

Moist Heat or Steam Sterilization

[00385640061568]

Moist Heat or Steam Sterilization

[00385640061568]

Moist Heat or Steam Sterilization

[00385640061568]

Moist Heat or Steam Sterilization

[00385640061568]

Moist Heat or Steam Sterilization

[00385640061568]

Moist Heat or Steam Sterilization

[00385640061568]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-27
• Device Publish Date: 2020-10-19

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