NovaSure NSV5-001

GUDID 15420045515154

Hologic, Inc.

Radio-frequency ablation system

• Primary Device ID: 15420045515154
• NIH Device Record Key: b8d90bae-3503-48c9-bf89-0c3afdae5cfa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NovaSure
• Version Model Number: V5
• Catalog Number: NSV5-001
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	15420045515154 [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

[15420045515154]

Ethylene Oxide

[15420045515154]

Ethylene Oxide

[15420045515154]

Ethylene Oxide

[15420045515154]

Ethylene Oxide

[15420045515154]

Ethylene Oxide

[15420045515154]

Ethylene Oxide

[15420045515154]

Ethylene Oxide

[15420045515154]

Ethylene Oxide

[15420045515154]

Ethylene Oxide

[15420045515154]

Ethylene Oxide

[15420045515154]

Ethylene Oxide

[15420045515154]

Ethylene Oxide

[15420045515154]

Ethylene Oxide

[15420045515154]

Ethylene Oxide

[15420045515154]

Ethylene Oxide

[15420045515154]

Ethylene Oxide

[15420045515154]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-01
• Device Publish Date: 2023-04-22

On-Brand Devices [NovaSure]

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