Omni Hysteroscopy Standard Set

GUDID 15420045510357

Hologic, Inc.

Rigid optical hysteroscope

• Primary Device ID: 15420045510357
• NIH Device Record Key: 53e6e625-5382-4bda-a4ac-606c363f3595
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omni Hysteroscopy Standard Set
• Version Model Number: 60-250-1
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045510357 [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

[15420045510357]

Moist Heat or Steam Sterilization

[15420045510357]

Moist Heat or Steam Sterilization

[15420045510357]

Moist Heat or Steam Sterilization

[15420045510357]

Moist Heat or Steam Sterilization

[15420045510357]

Moist Heat or Steam Sterilization

[15420045510357]

Moist Heat or Steam Sterilization

[15420045510357]

Moist Heat or Steam Sterilization

[15420045510357]

Moist Heat or Steam Sterilization

[15420045510357]

Moist Heat or Steam Sterilization

[15420045510357]

Moist Heat or Steam Sterilization

[15420045510357]

Moist Heat or Steam Sterilization

[15420045510357]

Moist Heat or Steam Sterilization

[15420045510357]

Moist Heat or Steam Sterilization

[15420045510357]

Moist Heat or Steam Sterilization

[15420045510357]

Moist Heat or Steam Sterilization

[15420045510357]

Moist Heat or Steam Sterilization

[15420045510357]

Moist Heat or Steam Sterilization

[15420045510357]

Moist Heat or Steam Sterilization

[15420045510357]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2018-12-10

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