Omni Hysteroscopy Standard Set

GUDID 15420045510357

Hologic, Inc.

Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope 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

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