MyoSure Tissue Removal Device 10-401

GUDID 15420045504813

Hologic, Inc.

Tissue morcellation system handpiece set

• Primary Device ID: 15420045504813
• NIH Device Record Key: 27c97822-fdfe-4b60-a231-e9708f780ba1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MyoSure Tissue Removal Device
• Version Model Number: 10-401
• Catalog Number: 10-401
• 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: 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	15420045504813 [Primary]
GS1	25420045504810 [Package]; Contains: 35420045504817; Package: CARTON [1 Units]; In Commercial Distribution
GS1	35420045504817 [Package]; Package: BOX [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142029

FDA Product Code

• HIH: HYSTEROSCOPE (AND ACCESSORIES)

Sterilization

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

[15420045504813]

Ethylene Oxide

[15420045504813]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-08

On-Brand Devices [MyoSure Tissue Removal Device]

• 25420045505107: 40-902
• 15420045505094: 50-501XL
• 15420045505087: 50-401XL
• 15420045505070: 30-401LITE
• 15420045504813: 10-401