GUDID 00385640027427

SUMMIT MEDICAL, INC.

Instrument tray

• Primary Device ID: 00385640027427
• NIH Device Record Key: ddb363a2-b0ea-4ee3-96f1-0ba323161710
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: OM-4631-GI
• 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	00385640027427 [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: 2017-03-10

Devices Manufactured by SUMMIT MEDICAL, INC.

• 00385640088510 - INSTRUSAFE: 2025-10-03
• 00385640088503 - INSTRUSAFE: 2025-10-01
• 00385640088480 - INSTRUSAFE: 2025-09-30
• 00385640088497 - INSTRUSAFE: 2025-09-30
• 00385640088466 - INSTRUSAFE: 2025-09-29
• 00385640088473 - INSTRUSAFE: 2025-09-29
• 00385640088398 - INSTRUSAFE: 2025-09-26
• 00385640088404 - INSTRUSAFE: 2025-09-26