Synergy™ Ablation System A000049

GUDID 00818354010312

Footswitch ASU2/ASU3

ATRICURE, INC.

Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator
Primary Device ID00818354010312
NIH Device Record Key0e8bae34-d514-4256-b190-aa21a70dc7b4
Commercial Distribution StatusIn Commercial Distribution
Brand NameSynergy™ Ablation System
Version Model NumberASU
Catalog NumberA000049
Company DUNS006133784
Company NameATRICURE, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx

Operating and Storage Conditions

Storage Environment TemperatureBetween -35 Degrees Celsius and 54 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -35 Degrees Celsius and 54 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -35 Degrees Celsius and 54 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -35 Degrees Celsius and 54 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -35 Degrees Celsius and 54 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -35 Degrees Celsius and 54 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -35 Degrees Celsius and 54 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100818354010312 [Primary]

FDA Product Code

OCMSurgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-08
Device Publish Date2019-12-31

On-Brand Devices [Synergy™ Ablation System]

00818354016291Glidepath Tape (1-Unit)
00818354010718Glidepath Tape (3-Unit)
00818354010596AtriCure Switch Box
00818354010558Isolator Synergy™ Surgical Ablation System Open, Short Jaw, Left Curve
00818354010503Isolator Synergy™ Surgical Ablation System Open, Long Jaw, Left Curve
00818354010206Ablation and Sensing Unit
00818354010312Footswitch ASU2/ASU3
30840143902318Isolator Synergy™ Surgical Ablation System Open, Short Jaw, Left Curve
30840143902141Isolator Synergy™ Surgical Ablation System Open, Long Jaw, Left Curve
30840143903018AtriCure Switch Box
30840143901625Glidepath Tape (3-Unit)

Trademark Results [Synergy]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SYNERGY
SYNERGY
98416154 not registered Live/Pending
SYNERGY - THE RETREAT SHOW LTD
2024-02-22
SYNERGY
SYNERGY
98400009 not registered Live/Pending
Zischke, Mark
2024-02-09
SYNERGY
SYNERGY
98377304 not registered Live/Pending
Transient Labs, Inc.
2024-01-26
SYNERGY
SYNERGY
97847048 not registered Live/Pending
Lathrop & Sons, Ltd
2023-03-20
SYNERGY
SYNERGY
97818546 not registered Live/Pending
Lasha Ronee Berry
2023-03-01
SYNERGY
SYNERGY
97818546 not registered Live/Pending
Leatha Loretta Robinson
2023-03-01
SYNERGY
SYNERGY
97682215 not registered Live/Pending
Synergy Homecare Franchising, L.L.C.
2022-11-17
SYNERGY
SYNERGY
97661575 not registered Live/Pending
Alchemy Arts LLC
2022-11-03
SYNERGY
SYNERGY
97650323 not registered Live/Pending
Everlast Roofing, Inc.
2022-10-27
SYNERGY
SYNERGY
97635674 not registered Live/Pending
Synergy Business Innovation & Solutions, Inc.
2022-10-17
SYNERGY
SYNERGY
97341886 not registered Live/Pending
Paragon Implant LLC
2022-03-31
SYNERGY
SYNERGY
97265013 not registered Live/Pending
Brest, Elan C
2022-02-13

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.