MyoSure Tissue Removal Device 40-902

GUDID 25420045505107

Hologic, Inc.

Tissue morcellation system handpiece set

• Primary Device ID: 25420045505107
• NIH Device Record Key: d411ccd1-0b5a-4820-9881-431be3c8f594
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MyoSure Tissue Removal Device
• Version Model Number: 40-902
• Catalog Number: 40-902
• 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	15420045505100 [Unit of Use]
GS1	25420045505107 [Primary]

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

[25420045505107]

Radiation Sterilization

[25420045505107]

Radiation Sterilization

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