7D Surgical Universal Tracking Sterilization Tray

GUDID 00628341521406

7D Surgical ULC

Device sterilization/disinfection container, reusable

• Primary Device ID: 00628341521406
• NIH Device Record Key: 01bbf3be-bd2e-49cb-959e-a246cb01586e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 7D Surgical Universal Tracking Sterilization Tray
• Version Model Number: 11-0143
• Company DUNS: 204326292
• Company Name: 7D Surgical ULC
• Device Count: 1
• DM Exempt: true
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628341521406 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192140

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[00628341521406]

Moist Heat or Steam Sterilization

[00628341521406]

Moist Heat or Steam Sterilization

[00628341521406]

Moist Heat or Steam Sterilization

[00628341521406]

Moist Heat or Steam Sterilization

[00628341521406]

Moist Heat or Steam Sterilization

[00628341521406]

Moist Heat or Steam Sterilization

[00628341521406]

Moist Heat or Steam Sterilization

[00628341521406]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-25
• Device Publish Date: 2025-09-17

On-Brand Devices [7D Surgical Universal Tracking Sterilization Tray]

• 00628341520782: 11-0084
• 00628341521406: 11-0143