NovaSure NSV5KITUS-001

GUDID 25420045514307

Hologic, Inc.

Radio-frequency ablation system

• Primary Device ID: 25420045514307
• NIH Device Record Key: 5ed39594-816f-489f-9003-fbec77e84b17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NovaSure
• Version Model Number: V5
• Catalog Number: NSV5KITUS-001
• 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: true
• Device Combination Product: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	25420045514307 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P010013

FDA Product Code

• MNB: Device, thermal ablation, endometrial

Sterilization

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

[25420045514307]

Ethylene Oxide

[25420045514307]

Ethylene Oxide

[25420045514307]

Ethylene Oxide

[25420045514307]

Ethylene Oxide

[25420045514307]

Ethylene Oxide

[25420045514307]

Ethylene Oxide

[25420045514307]

Ethylene Oxide

[25420045514307]

Ethylene Oxide

[25420045514307]

Ethylene Oxide

[25420045514307]

Ethylene Oxide

[25420045514307]

Ethylene Oxide

[25420045514307]

Ethylene Oxide

[25420045514307]

Ethylene Oxide

[25420045514307]

Ethylene Oxide

[25420045514307]

Ethylene Oxide

[25420045514307]

Ethylene Oxide

[25420045514307]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-12
• Device Publish Date: 2021-07-02

On-Brand Devices [NovaSure]

• 15420045501140: 2000
• 15420045501119: 2013
• 15420045500860: NovaSure Controller
• 15420045500853: NovaSure Controller
• 25420045514307: V5
• 15420045514300: V5
• 15420045514294: V5
• 15420045515154: V5