Argon Auxiliary Line (1.22 m) FPRCH6133

GUDID 00859019006141

Cryoablation System Accessory

GALIL MEDICAL INC.

General cryosurgical system, cryogen gas, electronic
Primary Device ID00859019006141
NIH Device Record Key35b7b8a5-5dd2-47f8-86da-a4c05a3c5dcc
Commercial Distribution StatusIn Commercial Distribution
Brand NameArgon Auxiliary Line (1.22 m)
Version Model NumberFPRCH6133
Catalog NumberFPRCH6133
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

Length1.22 Meter
Length1.22 Meter
Length1.22 Meter
Length1.22 Meter
Length1.22 Meter
Length1.22 Meter
Length1.22 Meter
Length1.22 Meter
Length1.22 Meter
Length1.22 Meter
Length1.22 Meter
Length1.22 Meter
Length1.22 Meter
Length1.22 Meter
Length1.22 Meter
Length1.22 Meter
Length1.22 Meter
Length1.22 Meter
Length1.22 Meter
Length1.22 Meter
Length1.22 Meter
Length1.22 Meter
Length1.22 Meter
Length1.22 Meter
Length1.22 Meter
Length1.22 Meter
Length1.22 Meter
Length1.22 Meter
Length1.22 Meter
Length1.22 Meter
Length1.22 Meter
Length1.22 Meter
Length1.22 Meter
Length1.22 Meter
Length1.22 Meter
Length1.22 Meter
Length1.22 Meter
Length1.22 Meter
Length1.22 Meter
Length1.22 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
GS100859019006141 [Primary]

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 Number2
Public Version Date2018-03-29
Device Publish Date2016-08-15

Devices Manufactured by GALIL MEDICAL INC.

07290104831171 - HEATfx 2.1 20cm Needle2020-11-09 Microwave ablation needle
07290104831188 - HEATfx 2.1 15cm Needle2020-11-09 Microwave ablation needle
00859019006936 - HEATfx Microwave Ablation System2020-10-02 Microwave ablation system console
00859019006394 - HEATfx Microwave Ablation System2020-08-24 Microwave ablation system console
00859019006400 - HEATfx Cart2020-08-24 Microwave Ablation System Accessory
07290104831140 - HEATfx 2.1 20cm Needle2020-08-24 Microwave ablation needle
07290104831157 - HEATfx 2.1 15cm Needle2020-08-24 Microwave ablation needle
00859019006417 - ICEfx Cryoablation System2020-03-30 Cryoablation System
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.