EZ CONNECT2™ Dual Cylinder Adapter, bar FPRCH4001

GUDID 00859019006011

Visual-ICE Cryoablation System Accessory

GALIL MEDICAL INC.

General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic General cryosurgical system, cryogen gas, electronic
Primary Device ID00859019006011
NIH Device Record Key303097e9-82e7-48df-9470-9056af6798f1
Commercial Distribution Discontinuation2017-11-15
Commercial Distribution StatusNot in Commercial Distribution
Brand NameEZ CONNECT2™ Dual Cylinder Adapter, bar
Version Model NumberFPRCH4001
Catalog NumberFPRCH4001
Company DUNS809529469
Company NameGALIL MEDICAL INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com
Phone651-287-5000
Emailgalil.cst@btgplc.com

Device Dimensions

Length8 Meter
Length8 Meter
Length8 Meter
Length8 Meter
Length8 Meter
Length8 Meter
Length8 Meter
Length8 Meter
Length8 Meter
Length8 Meter
Length8 Meter
Length8 Meter
Length8 Meter
Length8 Meter
Length8 Meter
Length8 Meter
Length8 Meter
Length8 Meter
Length8 Meter
Length8 Meter
Length8 Meter
Length8 Meter
Length8 Meter
Length8 Meter
Length8 Meter
Length8 Meter
Length8 Meter
Length8 Meter
Length8 Meter
Length8 Meter
Length8 Meter
Length8 Meter
Length8 Meter
Length8 Meter
Length8 Meter
Length8 Meter
Length8 Meter
Length8 Meter
Length8 Meter
Length8 Meter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in Visual-ICE Cryoablation System Storage Compartment
Special Storage Condition, SpecifyBetween 0 and 0 *Store in Visual-ICE Cryoablation System Storage Compartment
Special Storage Condition, SpecifyBetween 0 and 0 *Store in Visual-ICE Cryoablation System Storage Compartment
Special Storage Condition, SpecifyBetween 0 and 0 *Store in Visual-ICE Cryoablation System Storage Compartment
Special Storage Condition, SpecifyBetween 0 and 0 *Store in Visual-ICE Cryoablation System Storage Compartment
Special Storage Condition, SpecifyBetween 0 and 0 *Store in Visual-ICE Cryoablation System Storage Compartment
Special Storage Condition, SpecifyBetween 0 and 0 *Store in Visual-ICE Cryoablation System Storage Compartment
Special Storage Condition, SpecifyBetween 0 and 0 *Store in Visual-ICE Cryoablation System Storage Compartment
Special Storage Condition, SpecifyBetween 0 and 0 *Store in Visual-ICE Cryoablation System Storage Compartment
Special Storage Condition, SpecifyBetween 0 and 0 *Store in Visual-ICE Cryoablation System Storage Compartment
Special Storage Condition, SpecifyBetween 0 and 0 *Store in Visual-ICE Cryoablation System Storage Compartment
Special Storage Condition, SpecifyBetween 0 and 0 *Store in Visual-ICE Cryoablation System Storage Compartment
Special Storage Condition, SpecifyBetween 0 and 0 *Store in Visual-ICE Cryoablation System Storage Compartment
Special Storage Condition, SpecifyBetween 0 and 0 *Store in Visual-ICE Cryoablation System Storage Compartment
Special Storage Condition, SpecifyBetween 0 and 0 *Store in Visual-ICE Cryoablation System Storage Compartment
Special Storage Condition, SpecifyBetween 0 and 0 *Store in Visual-ICE Cryoablation System Storage Compartment
Special Storage Condition, SpecifyBetween 0 and 0 *Store in Visual-ICE Cryoablation System Storage Compartment
Special Storage Condition, SpecifyBetween 0 and 0 *Store in Visual-ICE Cryoablation System Storage Compartment
Special Storage Condition, SpecifyBetween 0 and 0 *Store in Visual-ICE Cryoablation System Storage Compartment
Special Storage Condition, SpecifyBetween 0 and 0 *Store in Visual-ICE Cryoablation System Storage Compartment
Special Storage Condition, SpecifyBetween 0 and 0 *Store in Visual-ICE Cryoablation System Storage Compartment
Special Storage Condition, SpecifyBetween 0 and 0 *Store in Visual-ICE Cryoablation System Storage Compartment
Special Storage Condition, SpecifyBetween 0 and 0 *Store in Visual-ICE Cryoablation System Storage Compartment
Special Storage Condition, SpecifyBetween 0 and 0 *Store in Visual-ICE Cryoablation System Storage Compartment
Special Storage Condition, SpecifyBetween 0 and 0 *Store in Visual-ICE Cryoablation System Storage Compartment
Special Storage Condition, SpecifyBetween 0 and 0 *Store in Visual-ICE Cryoablation System Storage Compartment
Special Storage Condition, SpecifyBetween 0 and 0 *Store in Visual-ICE Cryoablation System Storage Compartment
Special Storage Condition, SpecifyBetween 0 and 0 *Store in Visual-ICE Cryoablation System Storage Compartment
Special Storage Condition, SpecifyBetween 0 and 0 *Store in Visual-ICE Cryoablation System Storage Compartment
Special Storage Condition, SpecifyBetween 0 and 0 *Store in Visual-ICE Cryoablation System Storage Compartment
Special Storage Condition, SpecifyBetween 0 and 0 *Store in Visual-ICE Cryoablation System Storage Compartment
Special Storage Condition, SpecifyBetween 0 and 0 *Store in Visual-ICE Cryoablation System Storage Compartment
Special Storage Condition, SpecifyBetween 0 and 0 *Store in Visual-ICE Cryoablation System Storage Compartment
Special Storage Condition, SpecifyBetween 0 and 0 *Store in Visual-ICE Cryoablation System Storage Compartment
Special Storage Condition, SpecifyBetween 0 and 0 *Store in Visual-ICE Cryoablation System Storage Compartment
Special Storage Condition, SpecifyBetween 0 and 0 *Store in Visual-ICE Cryoablation System Storage Compartment
Special Storage Condition, SpecifyBetween 0 and 0 *Store in Visual-ICE Cryoablation System Storage Compartment
Special Storage Condition, SpecifyBetween 0 and 0 *Store in Visual-ICE Cryoablation System Storage Compartment
Special Storage Condition, SpecifyBetween 0 and 0 *Store in Visual-ICE Cryoablation System Storage Compartment
Special Storage Condition, SpecifyBetween 0 and 0 *Store in Visual-ICE Cryoablation System Storage Compartment

Device Identifiers

Device Issuing AgencyDevice ID
GS100859019006011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEHUnit, Cryosurgical, Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-10-17
Device Publish Date2016-08-15

On-Brand Devices [EZ CONNECT2™ Dual Cylinder Adapter, bar ]

00859019006202Visual-ICE Cryoablation System Accessory
00859019006011Visual-ICE Cryoablation System Accessory

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