Myosure XL for Fluent Device 50-601XL

GUDID 15420045507654

Hologic, Inc.

Tissue morcellation system handpiece, line-powered Tissue morcellation system handpiece Tissue morcellation system Tissue morcellation system

• Primary Device ID: 15420045507654
• NIH Device Record Key: c44e5995-3a6a-4a59-aad5-644f7f2015a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Myosure XL for Fluent Device
• Version Model Number: 50-601XL
• Catalog Number: 50-601XL
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045507654 [Primary]
GS1	25420045507651 [Package]; Package: BOX [1 Units]; In Commercial Distribution
GS1	35420045507658 [Package]; Contains: 25420045507651; Package: CARTON [1 Units]; In Commercial Distribution
GS1	45420045507655 [Package]; Contains: 25420045507651; Package: CARTON [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181974

FDA Product Code

• HIH: HYSTEROSCOPE (AND ACCESSORIES)

Sterilization

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

[15420045507654]

Ethylene Oxide

[15420045507654]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-04-09
• Device Publish Date: 2018-09-26

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