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 ID00842071109929
NIH Device Record Keyecf90ec1-c50b-481a-8e85-c66e5a7041ec
Commercial Distribution StatusIn Commercial Distribution
Brand NameAbeon Remora XL Smoke and Fluid Evacuation System
Version Model NumberST9020
Company DUNS038101861
Company NameAPPLIED MEDICAL TECHNOLOGY, INC.
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(440) 717-4000
Emailcs@appliedmedical.net

Device Identifiers

Device Issuing AgencyDevice ID
GS100842071109349 [Unit of Use]
GS100842071109929 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

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