INSTRUSSAFE

GUDID 00385640041287

SUMMIT MEDICAL, INC.

Instrument tray

• Primary Device ID: 00385640041287
• NIH Device Record Key: 3806b7db-bf2d-4509-80d9-e6897849f022
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INSTRUSSAFE
• Version Model Number: IN-2600-14-EN-018
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00385640041287 [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: 2
• Public Version Date: 2019-08-09
• Device Publish Date: 2018-12-08

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