Remora Smoke and Fluid Evacuation System EST9000, ST9000

GUDID 00842071139360

Remora Smoke and Fluid Evacuation System (Sterile, Pouched), MDR

APPLIED MEDICAL TECHNOLOGY, INC.

Surgical plume evacuation system

• Primary Device ID: 00842071139360
• NIH Device Record Key: d8232ceb-dc64-421b-8e91-81c999854a9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Remora Smoke and Fluid Evacuation System
• Version Model Number: EST9000
• Catalog Number: EST9000, ST9000
• Company DUNS: 038101861
• Company Name: APPLIED MEDICAL TECHNOLOGY, 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (440) 717-4000
• Email: cs@appliedmedical.net
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842071139346 [Primary]
GS1	00842071139360 [Package]; Contains: 00842071139346; Package: Box (ST9000) [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K971758

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-02
• Device Publish Date: 2024-11-22

On-Brand Devices [Remora Smoke and Fluid Evacuation System]

• 00842071139377: Remora Smoke and Fluid Evacuation System Micro (Sterile, Pouched), MDR
• 00842071139360: Remora Smoke and Fluid Evacuation System (Sterile, Pouched), MDR