MyoSure Tissue Removal System Control Unit 10-550

GUDID 15420045505124

Hologic, Inc.

Tissue morcellation system control unit

• Primary Device ID: 15420045505124
• NIH Device Record Key: 10443041-f914-4cce-a97a-578efb08de6b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MyoSure Tissue Removal System Control Unit
• Version Model Number: 10-550
• Catalog Number: 10-550
• Company DUNS: 018925968
• Company Name: Hologic, Inc.
• Device Count: 1
• DM Exempt: true
• 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

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 381 Millimeter of Mercury and 787 Millimeter of Mercury
• Storage Environment Humidity: Between 0 and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 381 Millimeter of Mercury and 787 Millimeter of Mercury
• Storage Environment Humidity: Between 0 and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 381 Millimeter of Mercury and 787 Millimeter of Mercury
• Storage Environment Humidity: Between 0 and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 381 Millimeter of Mercury and 787 Millimeter of Mercury
• Storage Environment Humidity: Between 0 and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 381 Millimeter of Mercury and 787 Millimeter of Mercury
• Storage Environment Humidity: Between 0 and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 381 Millimeter of Mercury and 787 Millimeter of Mercury
• Storage Environment Humidity: Between 0 and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 381 Millimeter of Mercury and 787 Millimeter of Mercury
• Storage Environment Humidity: Between 0 and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 381 Millimeter of Mercury and 787 Millimeter of Mercury
• Storage Environment Humidity: Between 0 and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 381 Millimeter of Mercury and 787 Millimeter of Mercury
• Storage Environment Humidity: Between 0 and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 381 Millimeter of Mercury and 787 Millimeter of Mercury
• Storage Environment Humidity: Between 0 and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 381 Millimeter of Mercury and 787 Millimeter of Mercury
• Storage Environment Humidity: Between 0 and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 381 Millimeter of Mercury and 787 Millimeter of Mercury
• Storage Environment Humidity: Between 0 and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 381 Millimeter of Mercury and 787 Millimeter of Mercury
• Storage Environment Humidity: Between 0 and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 381 Millimeter of Mercury and 787 Millimeter of Mercury
• Storage Environment Humidity: Between 0 and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 381 Millimeter of Mercury and 787 Millimeter of Mercury
• Storage Environment Humidity: Between 0 and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 381 Millimeter of Mercury and 787 Millimeter of Mercury

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045505124 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152723

FDA Product Code

• HIH: HYSTEROSCOPE (AND ACCESSORIES)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-05-19

On-Brand Devices [MyoSure Tissue Removal System Control Unit]

• 15420045505124: 10-550
• 15420045505117: 10-500