OWL 463-002-TC-S

GUDID 00825114000704

OWL GASSERIAN GANGLION R.F. PROBE/TEMPERATURE SENSOR

Diros Technology Inc

Percutaneous electrosurgical probe, denervation, monopolar, reusable
Primary Device ID00825114000704
NIH Device Record Key3a25ab74-1811-4a44-80dc-50a86876b7bf
Commercial Distribution StatusIn Commercial Distribution
Brand NameOWL
Version Model Number463-002-TC-S
Catalog Number463-002-TC-S
Company DUNS202738675
Company NameDiros Technology 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 Usefalse
Lot Batchtrue
Serial Numbertrue
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

Phone9054153440
EmailRBAKER@DIROSTECH.COM
Phone9054153440
EmailRBAKER@DIROSTECH.COM
Phone9054153440
EmailRBAKER@DIROSTECH.COM
Phone9054153440
EmailRBAKER@DIROSTECH.COM
Phone9054153440
EmailRBAKER@DIROSTECH.COM
Phone9054153440
EmailRBAKER@DIROSTECH.COM
Phone9054153440
EmailRBAKER@DIROSTECH.COM
Phone9054153440
EmailRBAKER@DIROSTECH.COM
Phone9054153440
EmailRBAKER@DIROSTECH.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100825114000704 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXIProbe, Radiofrequency Lesion

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00825114000704]

Moist Heat or Steam Sterilization


[00825114000704]

Moist Heat or Steam Sterilization


[00825114000704]

Moist Heat or Steam Sterilization


[00825114000704]

Moist Heat or Steam Sterilization


[00825114000704]

Moist Heat or Steam Sterilization


[00825114000704]

Moist Heat or Steam Sterilization


[00825114000704]

Moist Heat or Steam Sterilization


[00825114000704]

Moist Heat or Steam Sterilization


[00825114000704]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

On-Brand Devices [OWL]

825114008526OWL STERILE SINGLE USE DISPOSABLE SHARP CURVED RF INSULATED CANNULA (20 Ga.), 54mm LONG, 10MM BA
00825114008465INTERMEDIATE CABLE FOR NEUROTHERM TO OWL RE-USABLE TC PROBE/TEMPERATURE SENSOR
00825114008335OWL STERILE SINGLE USE DISPOSABLE RF INSULATED HYBRID CANNULA (23Ga.) 200mm LONG, 5mm BARE TIP
00825114008311OWL STERILE SINGLE USE DISPOSABLE RF INSULATED HYBRID CANNULA (23Ga.) 150mm LONG, 5mm BARE TIP
00825114008281OWL STERILE SINGLE USE DISPOSABLE RF INSULATED HYBRID CANNULA (23Ga.) 60mm LONG, 5mm BARE TIP
00825114008267OWL STERILE SINGLE USE DISPOSABLE BLUNT STRAIGHT RF INSULATED HYBRID CANNULA (22GA.), 150MM LONG
00825114008229OWL STERILE SINGLE USE DISPOSABLE BLUNT STRAIGHT RF INSULATED HYBRID CANNULA (22GA.), 100MM LONG
00825114008205OWL STERILE SINGLE USE DISPOSABLE BLUNT STRAIGHT RF INSULATED HYBRID CANNULA (22GA.), 100MM LONG
00825114008182OWL STERILE SINGLE USE DISPOSABLE BLUNT STRAIGHT RF INSULATED HYBRID CANNULA (22GA.), 100MM LONG
00825114008168OWL STERILE SINGLE USE DISPOSABLE BLUNT STRAIGHT RF INSULATED HYBRID CANNULA (22GA.), 54MM LONG,
00825114008144OWL STERILE SINGLE USE DISPOSABLE BLUNT CURVED RF INSULATED HYBRID CANNULA (22GA.), 150MM LONG,
00825114008120OWL STERILE SINGLE USE DISPOSABLE BLUNT CURVED RF INSULATED HYBRID CANNULA (22GA.), 150MM LONG,
00825114008106OWL STERILE SINGLE USE DISPOSABLE BLUNT CURVED RF INSULATED HYBRID CANNULA (22GA.), 100MM LONG,
00825114008083OWL STERILE SINGLE USE DISPOSABLE BLUNT CURVED RF INSULATED HYBRID CANNULA (22GA.), 100MM LONG,
00825114008069OWL STERILE SINGLE USE DISPOSABLE BLUNT CURVED RF INSULATED HYBRID CANNULA (22GA.), 50MM LONG, 5
00825114008045OWL STERILE SINGLE USE DISPOSABLE SHARP CURVED RF INSULATED HYBRID CANNULA (22GA.), 150MM LONG,
00825114008021OWL STERILE SINGLE USE DISPOSABLE SHARP CURVED RF INSULATED HYBRID CANNULA (22GA.), 150MM LONG,
00825114007987OWL STERILE SINGLE USE DISPOSABLE SHARP CURVED RF INSULATED HYBRID CANNULA (22 Ga.) 54mm LONG, 1
00825114007963OWL STERILE SINGLE USE DISPOSABLE SHARP CURVED RF INSULATED HYBRID CANNULA (22 Ga.) 54mm LONG, 5
00825114007949OWL STERILE SINGLE USE DISPOSABLE SHARP CURVED RF INSULATED HYBRID CANNULA (22GA.), 54MM LONG, 4
00825114007925OWL STERILE SINGLE USE DISPOSABLE SHARP CURVED RF INSULATED HYBRID CANNULA (22 Ga.) 50mm LONG, 1
00825114007895OWL STERILE SINGLE USE DISPOSABLE SHAPR CURVED RF INSULATED HYBRID CANNULA (22GA.), 50MM LONG, 4
00825114007871OWL STERILE SINGLE USE DISPOSABLE SHARP CURVED RF INSULATED HYBRID CANNULA (22GA.), 50MM LONG, 2
00825114007857OWL STERILE SINGLE USE DISPOSABLE RF INSULATED HYBRID CANNULA (22 Ga.) 150mm LONG, 10mm BARE TIP
00825114007833OWL STERILE SINGLE USE DISPOSABLE RF INSULATED HYBRID CANNULA (22 Ga.) 150mm LONG, 5mm BARE TIP
00825114007796OWL STERILE SINGLE USE DISPOSABLE RF INSULATED HYBRID CANNULA (22GA.), 100MM LONG, 2MM BARE TIP
00825114007772OWL STERILE SINGLE USE DISPOSABLE RF INSULATED HYBRID CANNULA (22GA.), 60MM LONG, 5MM BARE TIP
00825114007741OWL STERILE SINGLE USE DISPOSABLE RF INSULATED HYBRID CANNULA (22 Ga.) 54mm LONG, 2mm BARE TIP
00825114007727OWL STERILE SINGLE USE DISPOSABLE RF INSULATED HYBRID CANNULA (22 Ga.) 50mm LONG, 10mm BARE TIP
00825114007697OWL STERILE SINGLE USE DISPOSABLE RF INSULATED HYBRID CANNULA (22GA.), 50MM LONG, 4MM BARE TIP
00825114007673OWL STERILE SINGLE USE DISPOSABLE RF INSULATED HYBRID CANNULA (22GA.), 50MM LONG, 2MM BARE TIP
00825114007659OWL STERILE SINGLE USE DISPOSABLE BLUNT CURVED RF INSULATED HYBRID CANNULA (21GA.), 54MM LONG, 5
00825114007628OWL STERILE SINGLE USE DISPOSABLE RF INSULATED HYBRID CANNULA (21GA.), 100MM LONG, 5MM BARE TIP
00825114007604OWL STERILE SINGLE USE DISPOSABLE RF INSULATED HYBRID CANNULA (21GA.), 50MM LONG, 4MM BARE TIP
00825114007581OWL STERILE SINGLE USE DISPOSABLE RF INSULATED HYBRID CANNULA (21GA.), 50MM LONG, 2MM BARE TIP
00825114007567OWL STERILE SINGLE USE DISPOSABLE BLUNT STRAIGHT RF INSULATED HYBRID CANNULA (20GA.),150MM LONG,
00825114007543OWL STERILE SINGLE USE DISPOSABLE BLUNT STRAIGHT RF INSULATED HYBRID CANNULA (20GA.), 150MM LONG
00825114007529OWL STERILE SINGLE USE DISPOSABLE BLUNT STRAIGHT RF INSULATED HYBRID CANNULA (20GA.), 100MM LONG
00825114007505OWL STERILE SINGLE USE DISPOSABLE BLUNT STRAIGHT RF INSULATED HYBRID CANNULA (20GA.), 100MM LONG
00825114007482OWL STERILE SINGLE USE DISPOSABLE BLUNT STRAIGHT RF INSULATED HYBRID CANNULA (20GA.), 60MM LONG,
00825114007468OWL STERILE SINGLE USE DISPOSABLE BLUNT CURVED RF INSULATED HYBRID CANNULA (20GA.), 150MM LONG,
00825114007444OWL STERILE SINGLE USE DISPOSABLE BLUNT CURVED RF INSULATED HYBRID CANNULA (20GA.), 150MM LONG,
00825114007420OWL STERILE SINGLE USE DISPOSABLE BLUNT CURVED RF INSULATED HYBRID CANNULA (20GA.), 100MM LONG,
00825114007406OWL STERILE SINGLE USE DISPOSABLE BLUNT CURVED RF INSULATED HYBRID CANNULA (20GA.), 100MM LONG,
00825114007383OWL STERILE SINGLE USE DISPOSABLE SHARP CURVED RF INSULATED HYBRID CANNULA (20GA.), 200MM LONG,
00825114007369OWL STERILE SINGLE USE DISPOSABLE SHARP CURVED RF INSULATED HYBRID CANNULA (20 Ga.) 200mm LONG,
00825114007345OWL STERILE SINGLE USE DISPOSABLE SHARP CURVED RF INSULATED HYBRID CANNULA (20 Ga.) 200mm LONG,
00825114007314OWL STERILE SINGLE USE DISPOSABLE SHARP CURVED RF INSULATED HYBRID CANNULA (20 Ga.) 150mm LONG,
00825114007277OWL STERILE SINGLE USE DISPOSABLE SHARP CURVED RF INSULATED HYBRID CANNULA (20 GA.), 100MM LONG,
00825114007253OWL STERILE SINGLE USE DISPOSABLE SHARP CURVED RF INSULATED HYBRID CANNULA (20 GA.), 100MM LONG,

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.