INTRUSAFE

GUDID 00385640003407

SUMMIT MEDICAL, INC.

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• Primary Device ID: 00385640003407
• NIH Device Record Key: dddfa0fe-4ac5-4907-8a6a-6d0a3d8ee033
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTRUSAFE
• Version Model Number: IN-6310
• 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	00385640003407 [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: 2016-09-23

Devices Manufactured by SUMMIT MEDICAL, INC.

• 00385640080798 - INSTRUSAFE: 2024-04-25
• 00385640080804 - INSTRUSAFE: 2024-04-25
• 00385640080774 - INSTRUSAFE: 2024-04-24
• 00385640080781 - INSTRUSAFE: 2024-04-24
• 00385640017954 - INSTRUSAFE: 2024-04-22
• 00385640080712 - INSTRUSAFE: 2024-04-19
• 00385640080729 - INSTRUSAFE: 2024-04-19
• 00385640080736 - INSTRUSAFE: 2024-04-19