Omni Instrument Tray 60-903-1

GUDID 15420045516595

Global Omni Instrument Tray

Hologic, Inc.

Device sterilization/disinfection container, reusable

• Primary Device ID: 15420045516595
• NIH Device Record Key: 723d33f5-adb8-4b80-8137-2e9e092a4be7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omni Instrument Tray
• Version Model Number: 60-903-1
• Catalog Number: 60-903-1
• Company DUNS: 018925968
• Company Name: Hologic, 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: 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

Customer Support Contacts

• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045516595 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182052

FDA Product Code

• KCT: Sterilization wrap containers, trays, cassettes & other accessories

Sterilization

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

[15420045516595]

Moist Heat or Steam Sterilization

[15420045516595]

Moist Heat or Steam Sterilization

[15420045516595]

Moist Heat or Steam Sterilization

[15420045516595]

Moist Heat or Steam Sterilization

[15420045516595]

Moist Heat or Steam Sterilization

[15420045516595]

Moist Heat or Steam Sterilization

[15420045516595]

Moist Heat or Steam Sterilization

[15420045516595]

Moist Heat or Steam Sterilization

[15420045516595]

Moist Heat or Steam Sterilization

[15420045516595]

Moist Heat or Steam Sterilization

[15420045516595]

Moist Heat or Steam Sterilization

[15420045516595]

Moist Heat or Steam Sterilization

[15420045516595]

Moist Heat or Steam Sterilization

[15420045516595]

Moist Heat or Steam Sterilization

[15420045516595]

Moist Heat or Steam Sterilization

[15420045516595]

Moist Heat or Steam Sterilization

[15420045516595]

Moist Heat or Steam Sterilization

[15420045516595]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-25
• Device Publish Date: 2023-10-17

On-Brand Devices [Omni Instrument Tray]

• 15420045510296: 60-903
• 15420045516595: Global Omni Instrument Tray