30 Degree Omni Hysteroscope XL Outflow Channel

GUDID 15420045513662

Hologic, Inc.

Rigid optical hysteroscope

• Primary Device ID: 15420045513662
• NIH Device Record Key: bfd1bb04-bc58-495c-ba4a-b61000b007b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 30 Degree Omni Hysteroscope XL Outflow Channel
• Version Model Number: 50-201XL-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	15420045513662 [Primary]
GS1	25420045513669 [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

[15420045513662]

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[15420045513662]

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[15420045513662]

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[15420045513662]

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[15420045513662]

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[15420045513662]

Moist Heat or Steam Sterilization

[15420045513662]

Moist Heat or Steam Sterilization

[15420045513662]

Moist Heat or Steam Sterilization

[15420045513662]

Moist Heat or Steam Sterilization

[15420045513662]

Moist Heat or Steam Sterilization

[15420045513662]

Moist Heat or Steam Sterilization

[15420045513662]

Moist Heat or Steam Sterilization

[15420045513662]

Moist Heat or Steam Sterilization

[15420045513662]

Moist Heat or Steam Sterilization

[15420045513662]

Moist Heat or Steam Sterilization

[15420045513662]

Moist Heat or Steam Sterilization

[15420045513662]

Moist Heat or Steam Sterilization

[15420045513662]

Moist Heat or Steam Sterilization

[15420045513662]

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[15420045513662]

Moist Heat or Steam Sterilization

[15420045513662]

Moist Heat or Steam Sterilization

[15420045513662]

Moist Heat or Steam Sterilization

[15420045513662]

Moist Heat or Steam Sterilization

[15420045513662]

Moist Heat or Steam Sterilization

[15420045513662]

Moist Heat or Steam Sterilization

[15420045513662]

Moist Heat or Steam Sterilization

[15420045513662]

Moist Heat or Steam Sterilization

[15420045513662]

Moist Heat or Steam Sterilization

[15420045513662]

Moist Heat or Steam Sterilization

[15420045513662]

Moist Heat or Steam Sterilization

[15420045513662]

Moist Heat or Steam Sterilization

[15420045513662]

Moist Heat or Steam Sterilization

[15420045513662]

Moist Heat or Steam Sterilization

[15420045513662]

Moist Heat or Steam Sterilization

[15420045513662]

Moist Heat or Steam Sterilization

[15420045513662]

Moist Heat or Steam Sterilization

[15420045513662]

Moist Heat or Steam Sterilization

[15420045513662]

Moist Heat or Steam Sterilization

[15420045513662]

Moist Heat or Steam Sterilization

[15420045513662]

Moist Heat or Steam Sterilization

[15420045513662]

Moist Heat or Steam Sterilization

[15420045513662]

Moist Heat or Steam Sterilization

[15420045513662]

Moist Heat or Steam Sterilization

[15420045513662]

Moist Heat or Steam Sterilization

[15420045513662]

Moist Heat or Steam Sterilization

[15420045513662]

Moist Heat or Steam Sterilization

[15420045513662]

Moist Heat or Steam Sterilization

[15420045513662]

Moist Heat or Steam Sterilization

[15420045513662]

Moist Heat or Steam Sterilization

[15420045513662]

Moist Heat or Steam Sterilization

[15420045513662]

Moist Heat or Steam Sterilization

[15420045513662]

Moist Heat or Steam Sterilization

[15420045513662]

Moist Heat or Steam Sterilization

[15420045513662]

Moist Heat or Steam Sterilization

[15420045513662]

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

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