Abeon Remora XL Smoke and Fluid Evacuation System

GUDID 00842071109929

Smoke and Fluid Evacuation System XL (Box 10)

APPLIED MEDICAL TECHNOLOGY, INC.

Surgical fluid/smoke waste management system suction unit

• Primary Device ID: 00842071109929
• NIH Device Record Key: ecf90ec1-c50b-481a-8e85-c66e5a7041ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Abeon Remora XL Smoke and Fluid Evacuation System
• Version Model Number: ST9020
• Company DUNS: 038101861
• Company Name: APPLIED MEDICAL TECHNOLOGY, INC.
• Device Count: 10
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842071109349 [Unit of Use]
GS1	00842071109929 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

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