Prostate Procedure Template SPR000018

GUDID 07290104830525

Prostate Procedure Template for use with Galil Medical 1.5 mm Shaft Diameter Cryoablation Needles

GALIL MEDICAL LTD

Cryosurgical set
Primary Device ID07290104830525
NIH Device Record Keydb38c5cd-8ada-4364-8146-23bc55a03170
Commercial Distribution StatusIn Commercial Distribution
Brand NameProstate Procedure Template
Version Model NumberSPR000018
Catalog NumberSPR000018
Company DUNS531854560
Company NameGALIL MEDICAL LTD
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 Datetrue
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

Device Dimensions

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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a manner that will not mar the prostate Procedure Template surface or damage the precision holes
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a manner that will not mar the prostate Procedure Template surface or damage the precision holes
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a manner that will not mar the prostate Procedure Template surface or damage the precision holes
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a manner that will not mar the prostate Procedure Template surface or damage the precision holes
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a manner that will not mar the prostate Procedure Template surface or damage the precision holes
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a manner that will not mar the prostate Procedure Template surface or damage the precision holes
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a manner that will not mar the prostate Procedure Template surface or damage the precision holes
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a manner that will not mar the prostate Procedure Template surface or damage the precision holes
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a manner that will not mar the prostate Procedure Template surface or damage the precision holes
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a manner that will not mar the prostate Procedure Template surface or damage the precision holes
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a manner that will not mar the prostate Procedure Template surface or damage the precision holes
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a manner that will not mar the prostate Procedure Template surface or damage the precision holes
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a manner that will not mar the prostate Procedure Template surface or damage the precision holes
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a manner that will not mar the prostate Procedure Template surface or damage the precision holes
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a manner that will not mar the prostate Procedure Template surface or damage the precision holes
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a manner that will not mar the prostate Procedure Template surface or damage the precision holes
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a manner that will not mar the prostate Procedure Template surface or damage the precision holes
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a manner that will not mar the prostate Procedure Template surface or damage the precision holes
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a manner that will not mar the prostate Procedure Template surface or damage the precision holes
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a manner that will not mar the prostate Procedure Template surface or damage the precision holes
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a manner that will not mar the prostate Procedure Template surface or damage the precision holes
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a manner that will not mar the prostate Procedure Template surface or damage the precision holes
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a manner that will not mar the prostate Procedure Template surface or damage the precision holes
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a manner that will not mar the prostate Procedure Template surface or damage the precision holes

Device Identifiers

Device Issuing AgencyDevice ID
GS107290104830525 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEHUnit, Cryosurgical, Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07290104830525]

Moist Heat or Steam Sterilization


[07290104830525]

Moist Heat or Steam Sterilization


[07290104830525]

Moist Heat or Steam Sterilization


[07290104830525]

Moist Heat or Steam Sterilization


[07290104830525]

Moist Heat or Steam Sterilization


[07290104830525]

Moist Heat or Steam Sterilization


[07290104830525]

Moist Heat or Steam Sterilization


[07290104830525]

Moist Heat or Steam Sterilization


[07290104830525]

Moist Heat or Steam Sterilization


[07290104830525]

Moist Heat or Steam Sterilization


[07290104830525]

Moist Heat or Steam Sterilization


[07290104830525]

Moist Heat or Steam Sterilization


[07290104830525]

Moist Heat or Steam Sterilization


[07290104830525]

Moist Heat or Steam Sterilization


[07290104830525]

Moist Heat or Steam Sterilization


[07290104830525]

Moist Heat or Steam Sterilization


[07290104830525]

Moist Heat or Steam Sterilization


[07290104830525]

Moist Heat or Steam Sterilization


[07290104830525]

Moist Heat or Steam Sterilization


[07290104830525]

Moist Heat or Steam Sterilization


[07290104830525]

Moist Heat or Steam Sterilization


[07290104830525]

Moist Heat or Steam Sterilization


[07290104830525]

Moist Heat or Steam Sterilization


[07290104830525]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-02-15

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07290104830082 - IceRod® Prostate Cryoablation Kit / SeedNet® Syste2018-07-06 Prostate Kit including Cryoablation Needles, Thermal Sensor, Urethral Warming Set, Prostate Template
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