999-199

GUDID 00385640071086

Summit Medical, Inc.

Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable

• Primary Device ID: 00385640071086
• NIH Device Record Key: ff469732-e9ca-49a6-b0d7-b21841270189
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: OM-1000-TN
• Catalog Number: 999-199
• 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	00385640071086 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-29
• Device Publish Date: 2022-06-21

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