Isolator Surgical Ablation System A000318

GUDID 00818354010473

Isolator Linear Pen, 20 mm linear electrode

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 Cardiac radio-frequency ablation system generator
Primary Device ID00818354010473
NIH Device Record Key329de022-47d0-46d1-a18a-bf79a927264a
Commercial Distribution StatusIn Commercial Distribution
Brand NameIsolator Surgical Ablation System
Version Model NumberMLP1
Catalog NumberA000318
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
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
Phone866-349-2342
Emailxxx@xxx.xxx

Device Dimensions

Length20 Millimeter
Length20 Millimeter
Length20 Millimeter
Length20 Millimeter
Length20 Millimeter
Length20 Millimeter
Length20 Millimeter
Length20 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100818354010473 [Primary]

FDA Product Code

OCLSurgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-27
Device Publish Date2016-10-24

On-Brand Devices [Isolator Surgical Ablation System]

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00818354011326Glidepath Tape (3-Unit)
00818354011135Isolator Long Pen TT, 33 cm long pen
00818354011043Isolator Synergy Access Surgical Ablation System
00818354010893Coolrail Linear Pen, 30 mm linear electrode
00818354010824Isolator Synergy Surgical Ablation System, Glidepath Tape, Left Curve
00818354010756Isolator Synergy Surgical Ablation System, Glidepath Tape, Right Curve
00818354010473Isolator Linear Pen, 20 mm linear electrode
00818354010435Glidepath Tape (3-Unit)
00818354010343Isolator Transpolar Pen
00818354016499Coolrail Linear Pen, 30 mm linear electrode
30840143902103Isolator Linear Pen, 20 mm linear electrode
30840143902523Isolator Long Pen TT, 33 cm long pen
30840143902455Coolrail Linear Pen, 30 mm linear electrode
30840143902387Isolator Synergy Surgical Ablation System, Glidepath Tape, Left Curve
30840143902257Isolator Synergy Surgical Ablation System, Glidepath Tape, Right Curve
30840143901984Isolator Transpolar Pen
30840143900000Isolator Synergy Access Surgical Ablation System
30840143901618Glidepath Tape (GPT200) (3-Unit)
30840143901595Glidepath Tape (GPT100) (1-Unit)

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