INSTRUSFAE

GUDID 00385640028578

SUMMIT MEDICAL, INC.

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• Primary Device ID: 00385640028578
• NIH Device Record Key: f459b830-b01b-4bcd-bb7e-b0302b58d621
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INSTRUSFAE
• Version Model Number: IN-2020-1725
• 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: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00385640028578 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051157

FDA Product Code

• KCT: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-08-09
• Device Publish Date: 2017-06-10

On-Brand Devices [INSTRUSFAE]

• 00385640028639: IN-2020-1744
• 00385640028578: IN-2020-1725
• 00385640004503: IN-7274-NF