Habib

GUDID H7874401S1

RITA Habib 4X Bipolar Resection Device, 6cm

NAVILYST MEDICAL, INC.

Percutaneous electrosurgical probe, tumour-ablation, monopolar Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar

• Primary Device ID: H7874401S1
• NIH Device Record Key: 5a2eb5e8-b82e-452c-9758-8f93dd5bd4c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Habib
• Version Model Number: 4401S
• Company DUNS: 809699023
• Company Name: NAVILYST MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com

Device Dimensions

• Length: 6 Centimeter
• Length: 6 Centimeter
• Length: 6 Centimeter
• Length: 6 Centimeter
• Length: 6 Centimeter
• Length: 6 Centimeter
• Length: 6 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	15051684017367 [Secondary]
HIBCC	H7874401S1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051420

FDA Product Code

• GEI: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-04-23
• Device Publish Date: 2016-09-26

On-Brand Devices [Habib]

• H7877001036591: RITA Habib 4X Laparoscopic Electrosurgical Device
• H7874401S1: RITA Habib 4X Bipolar Resection Device, 6cm
• H7874401L1: RITA Habib 4X Bipolar Resection Device, 10cm
• H78744011: RITA Habib 4X Bipolar Resection Device