Myosure Manual Tissue Removal Device 20-401ML

GUDID 15420045507937

Hologic, Inc.

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

• Primary Device ID: 15420045507937
• NIH Device Record Key: b59338aa-6ad5-435d-9913-02af30a8f13a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Myosure Manual Tissue Removal Device
• Version Model Number: 20-401ML
• Catalog Number: 20-401ML
• Company DUNS: 018925968
• Company Name: Hologic, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• 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	15420045507937 [Primary]
GS1	25420045507934 [Package]; Package: CARTON [1 Units]; In Commercial Distribution
GS1	35420045507931 [Package]; Contains: 25420045507934; Package: BOX [1 Units]; In Commercial Distribution
GS1	45420045507938 [Package]; Contains: 25420045507934; Package: BOX [3 Units]; In Commercial Distribution

FDA Product Code

• HIH: HYSTEROSCOPE (AND ACCESSORIES)
• NWW: Hysteroscope accessories

Sterilization

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

[15420045507937]

Ethylene Oxide

[15420045507937]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2018-01-08

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