Omni Hysteroscopy Standard Set 60-250-1

GUDID 25420045510354

The OMNI™ Hysteroscope is used to provide viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.

Hologic, Inc.

Rigid optical hysteroscope

• Primary Device ID: 25420045510354
• NIH Device Record Key: 5d468d4d-7d94-4a49-bcd0-e2d51403b663
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omni Hysteroscopy Standard Set
• Version Model Number: 60-250-1
• Catalog Number: 60-250-1
• Company DUNS: 018925968
• Company Name: Hologic, Inc.
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	25420045510354 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182006

FDA Product Code

• HIH: Hysteroscope (And Accessories)

Sterilization

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

[25420045510354]

Moist Heat or Steam Sterilization

[25420045510354]

Moist Heat or Steam Sterilization

[25420045510354]

Moist Heat or Steam Sterilization

[25420045510354]

Moist Heat or Steam Sterilization

[25420045510354]

Moist Heat or Steam Sterilization

[25420045510354]

Moist Heat or Steam Sterilization

[25420045510354]

Moist Heat or Steam Sterilization

[25420045510354]

Moist Heat or Steam Sterilization

[25420045510354]

Moist Heat or Steam Sterilization

[25420045510354]

Moist Heat or Steam Sterilization

[25420045510354]

Moist Heat or Steam Sterilization

[25420045510354]

Moist Heat or Steam Sterilization

[25420045510354]

Moist Heat or Steam Sterilization

[25420045510354]

Moist Heat or Steam Sterilization

[25420045510354]

Moist Heat or Steam Sterilization

[25420045510354]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-04
• Device Publish Date: 2024-09-26

On-Brand Devices [Omni Hysteroscopy Standard Set]

• 15420045510357: 60-250-1
• 25420045510354: The OMNI™ Hysteroscope is used to provide viewing of the cervical canal and the uterine cavity