MYOSURE HYSTEROSCOPY SET

GUDID 15420045510326

Hologic, Inc.

Rigid optical hysteroscope

• Primary Device ID: 15420045510326
• NIH Device Record Key: 5671a4ae-f213-41f6-9188-167131ede194
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MYOSURE HYSTEROSCOPY SET
• Version Model Number: 40-250
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045510326 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091465

FDA Product Code

• HIH: HYSTEROSCOPE (AND ACCESSORIES)

Sterilization

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

[15420045510326]

Moist Heat or Steam Sterilization

[15420045510326]

Moist Heat or Steam Sterilization

[15420045510326]

Moist Heat or Steam Sterilization

[15420045510326]

Moist Heat or Steam Sterilization

[15420045510326]

Moist Heat or Steam Sterilization

[15420045510326]

Moist Heat or Steam Sterilization

[15420045510326]

Moist Heat or Steam Sterilization

[15420045510326]

Moist Heat or Steam Sterilization

[15420045510326]

Moist Heat or Steam Sterilization

[15420045510326]

Moist Heat or Steam Sterilization

[15420045510326]

Moist Heat or Steam Sterilization

[15420045510326]

Moist Heat or Steam Sterilization

[15420045510326]

Moist Heat or Steam Sterilization

[15420045510326]

Moist Heat or Steam Sterilization

[15420045510326]

Moist Heat or Steam Sterilization

[15420045510326]

Moist Heat or Steam Sterilization

[15420045510326]

Moist Heat or Steam Sterilization

[15420045510326]

Moist Heat or Steam Sterilization

[15420045510326]

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: 2018-10-03

On-Brand Devices [MYOSURE HYSTEROSCOPY SET]

• 25420045510323: 40-250
• 15420045510326: 40-250