MyoSure Tissue Removal System Control Unit 10-500

GUDID 15420045505117

Hologic, Inc.

Tissue morcellation system control unit

• Primary Device ID: 15420045505117
• NIH Device Record Key: ec96fd87-7abb-4bc4-a585-bfc5964e34b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MyoSure Tissue Removal System Control Unit
• Version Model Number: 10-500
• Catalog Number: 10-500
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045505117 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142029

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