cryoICE Cryoablation System A000925

GUDID 30840143902721

cryoICE 10cm Cryoablation Probe

ATRICURE, INC.

General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical
Primary Device ID30840143902721
NIH Device Record Key1b046b4b-93b8-42e9-8b11-b151bb35420e
Commercial Distribution StatusIn Commercial Distribution
Brand NamecryoICE Cryoablation System
Version Model NumberCRYO3
Catalog NumberA000925
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
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
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
Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx

Device Dimensions

Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100818354016130 [Previous]
GS110840143902383 [Primary]
GS130840143902721 [Package]
Contains: 10840143902383
Package: box [1 Units]
In Commercial Distribution
GS150840143902664 [Package]
Package: case [3 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEHUnit, Cryosurgical, Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-18
Device Publish Date2021-01-08

On-Brand Devices [cryoICE Cryoablation System]

00818354016277cryoICE Cryoablation System Cryo Module
00818354016147cryoICE cryoFORM 10 cm Corrugated Stainless Steel Cryoablation Probe
00818354016130cryoICE CRYO3 10 cm Smooth Aluminum Cryoablation Probe
00818354016123cryoICE CRYO2 10 cm Smooth Aluminum Cryoablation Probe
00818354015782ACM Accessories
00818354014839cryoICE cryoFORM 10 cm Corrugated Stainless Steel Cryoablation Probe
00818354014549cryoICE CRYO3 10 cm Smooth Aluminum Cryoablation Probe
00818354011470cryoICE Cryoablation System Cryo Module
00818354011340cryoICE CRYO2 10 cm Smooth Aluminum Cryoablation Probe
00818354016796cryoICE Cryoablation System Cryo Module
00818354012705ACM Footswitch
10840143902925ACM Footswitch
30840143902837cryoICE cryoFORM 10 cm Corrugated Stainless Steel Cryoablation Probe
30840143902721cryoICE 10cm Cryoablation Probe
30840143902608cryoICE 10cm Cryoablation Probe
10840143900426cryoICE Cryoablation System Cryo Module

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