GUDID 00385640023849

SUMMIT MEDICAL, INC.

Middle ear decompressor, positive pressure

• Primary Device ID: 00385640023849
• NIH Device Record Key: 737a7b52-6e21-443c-9da7-e0a0948c3c9c
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: EP-2100
• 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: false
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00385640023849 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073401

FDA Product Code

• MJV: Device, Inflation, Middle Ear

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-11

Devices Manufactured by SUMMIT MEDICAL, INC.

• 00385640083935 - INSTRUSAFE: 2024-11-21
• 00385640083904 - INSTRUSAFE: 2024-11-20
• 00385640083911 - INSTRUSAFE: 2024-11-20
• 00385640083928 - INSTRUSAFE: 2024-11-20
• 00385640083881 - INSTRUSAFE: 2024-11-19
• 00385640083898 - INSTRUSAFE: 2024-11-19
• 00385640083874 - INSTRUSAFE: 2024-11-18
• 00385640083836 - INSTRUSAFE: 2024-11-15