GUDID 00385640002431

SUMMIT MEDICAL, INC.

Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure Middle ear decompressor, positive pressure

• Primary Device ID: 00385640002431
• NIH Device Record Key: 3cf8a190-0408-47dc-b77f-33e45cd1047e
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: EP-1010
• 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	00385640002431 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-26
• Device Publish Date: 2021-05-18

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• 00385640080729 - INSTRUSAFE: 2024-04-19
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