30 Degree Omni Hysteroscope

GUDID 25420045513560

Hologic, Inc.

Rigid optical hysteroscope

• Primary Device ID: 25420045513560
• NIH Device Record Key: 19b74407-7e15-4abe-a58a-40d323418ef3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 30 Degree Omni Hysteroscope
• Version Model Number: 60-200-30
• 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	25420045513560 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191281

FDA Product Code

• HIH: HYSTEROSCOPE (AND ACCESSORIES)

Sterilization

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

[25420045513560]

Moist Heat or Steam Sterilization

[25420045513560]

Moist Heat or Steam Sterilization

[25420045513560]

Moist Heat or Steam Sterilization

[25420045513560]

Moist Heat or Steam Sterilization

[25420045513560]

Moist Heat or Steam Sterilization

[25420045513560]

Moist Heat or Steam Sterilization

[25420045513560]

Moist Heat or Steam Sterilization

[25420045513560]

Moist Heat or Steam Sterilization

[25420045513560]

Moist Heat or Steam Sterilization

[25420045513560]

Moist Heat or Steam Sterilization

[25420045513560]

Moist Heat or Steam Sterilization

[25420045513560]

Moist Heat or Steam Sterilization

[25420045513560]

Moist Heat or Steam Sterilization

[25420045513560]

Moist Heat or Steam Sterilization

[25420045513560]

Moist Heat or Steam Sterilization

[25420045513560]

Moist Heat or Steam Sterilization

[25420045513560]

Moist Heat or Steam Sterilization

[25420045513560]

Moist Heat or Steam Sterilization

[25420045513560]

Moist Heat or Steam Sterilization

[25420045513560]

Moist Heat or Steam Sterilization

[25420045513560]

Moist Heat or Steam Sterilization

[25420045513560]

Moist Heat or Steam Sterilization

[25420045513560]

Moist Heat or Steam Sterilization

[25420045513560]

Moist Heat or Steam Sterilization

[25420045513560]

Moist Heat or Steam Sterilization

[25420045513560]

Moist Heat or Steam Sterilization

[25420045513560]

Moist Heat or Steam Sterilization

[25420045513560]

Moist Heat or Steam Sterilization

[25420045513560]

Moist Heat or Steam Sterilization

[25420045513560]

Moist Heat or Steam Sterilization

[25420045513560]

Moist Heat or Steam Sterilization

[25420045513560]

Moist Heat or Steam Sterilization

[25420045513560]

Moist Heat or Steam Sterilization

[25420045513560]

Moist Heat or Steam Sterilization

[25420045513560]

Moist Heat or Steam Sterilization

[25420045513560]

Moist Heat or Steam Sterilization

[25420045513560]

Moist Heat or Steam Sterilization

[25420045513560]

Moist Heat or Steam Sterilization

[25420045513560]

Moist Heat or Steam Sterilization

[25420045513560]

Moist Heat or Steam Sterilization

[25420045513560]

Moist Heat or Steam Sterilization

[25420045513560]

Moist Heat or Steam Sterilization

[25420045513560]

Moist Heat or Steam Sterilization

[25420045513560]

Moist Heat or Steam Sterilization

[25420045513560]

Moist Heat or Steam Sterilization

[25420045513560]

Moist Heat or Steam Sterilization

[25420045513560]

Moist Heat or Steam Sterilization

[25420045513560]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-15
• Device Publish Date: 2020-10-07

On-Brand Devices [30 Degree Omni Hysteroscope]

• 25420045513560: 60-200-30
• 15420045513563: 60-200-30