Acessa ProVu System 7100

GUDID 15420045515307

Hologic, Inc.

Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system Radio-frequency ablation system

• Primary Device ID: 15420045515307
• NIH Device Record Key: 4c2f43c5-6c10-4f9a-95ac-3bf1c5c7666b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acessa ProVu System
• Version Model Number: 7100
• Catalog Number: 7100
• 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: false
• Lot Batch: false
• Serial Number: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -34 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045515307 [Primary]

FDA Product Code

• HFG: COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-24
• Device Publish Date: 2023-05-16

On-Brand Devices [Acessa ProVu System]

• 15420045515284: 5200
• 15420045515314: MS-06-0171
• 15420045515307: 7100
• 15420045515253: 3000
• 15420045515246: 7300