Myosure Reach Tissue Removal Device 10-401FC

GUDID 25420045504537

The MyoSure Tissue Removal System is intended for hysteroscopic intrauterine resection procedures by a trained gynecologist to hysteroscopically resect and remove tissue such as submucous myomas, endometrial polyps, and retained products of conception.

Hologic, Inc.

Tissue morcellation system Tissue morcellation system Tissue morcellation system Tissue morcellation system Tissue morcellation system Tissue morcellation system Tissue morcellation system Tissue morcellation system Tissue morcellation system Tissue morcellation system Tissue morcellation system Tissue morcellation system Tissue morcellation system Tissue morcellation system Tissue morcellation system Tissue morcellation system Tissue morcellation system Tissue morcellation system

• Primary Device ID: 25420045504537
• NIH Device Record Key: 48a75ec9-2ef1-4bf2-8a5a-3807e46502dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Myosure Reach Tissue Removal Device
• Version Model Number: 10-401FC
• Catalog Number: 10-401FC
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045504530 [Primary]
GS1	25420045504537 [Package]; Contains: 15420045504530; Package: CARTON [1 Units]; In Commercial Distribution
GS1	35420045504534 [Package]; Package: BOX [3 Units]; In Commercial Distribution

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: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-03
• Device Publish Date: 2023-07-26

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