30 Degree Omni Hysteroscope Outflow Channel

GUDID 15420045513655

Hologic, Inc.

Rigid optical hysteroscope

• Primary Device ID: 15420045513655
• NIH Device Record Key: a262ceda-aab5-4485-b378-5a7dfd6bdf44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 30 Degree Omni Hysteroscope Outflow Channel
• Version Model Number: 40-201-30
• 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: 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: false
• 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
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045513655 [Primary]
GS1	25420045513652 [Package]; Package: EACH [1 Units]; In Commercial Distribution

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

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

Moist Heat or Steam Sterilization

[15420045513655]

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

Devices Manufactured by Hologic, Inc.

• 15420045517394 - Hologic: 2025-09-05 NG Res Primers Analyte Specific Reagent.
• 15420045517400 - Hologic: 2025-09-05 NG Res Probe (FAM) Analyte Specific Reagent.
• 15420045517417 - Hologic: 2025-09-05 NG Res C272T IVT Control (Positive Control).
• 15420045517424 - Hologic: 2025-09-05 NG IVT Wild Type Control (Negative Control).
• 15420045512412 - DEFINITY CERVICAL DILATOR, 5MM: 2025-07-29
• 15420045512429 - DEFINITY CERVICAL DILATOR, 7MM: 2025-07-29
• 15420045512436 - DEFINITY CERVICAL DILATOR, 9MM: 2025-07-29
• 15420045517097 - DIGITAL DIAGNOSTICS SYSTEM: 2025-07-25 Computer to operate the Genius™ Review Station.