OWL D463-005

GUDID 00825114003064

OWL STERILE SINGLE USE DISPOSABLE GASSERIAN GANGLION RF INSULATED CANNULA (19GA), 105MM LONG, 5MM BARE TIP

Diros Technology Inc

Radio-frequency ablation system probe cannula, single-use Radio-frequency ablation system probe cannula, single-use Percutaneous radio-frequency ablation system probe cannula, single-use Percutaneous radio-frequency ablation system probe cannula, single-use Percutaneous radio-frequency ablation system probe cannula, single-use Percutaneous radio-frequency ablation system probe cannula, single-use Percutaneous radio-frequency ablation system probe cannula, single-use Percutaneous radio-frequency ablation system probe cannula, single-use Percutaneous radio-frequency ablation system probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use

Primary Device ID	00825114003064
NIH Device Record Key	1a592d9c-d8e2-4d2c-9d30-7430693b0560
Commercial Distribution Status	In Commercial Distribution
Brand Name	OWL
Version Model Number	D463-005
Catalog Number	D463-005
Company DUNS	202738675
Company Name	Diros Technology Inc
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	9054153440
Email	RBAKER@DIROSTECH.COM
Phone	9054153440
Email	RBAKER@DIROSTECH.COM
Phone	9054153440
Email	RBAKER@DIROSTECH.COM
Phone	9054153440
Email	RBAKER@DIROSTECH.COM
Phone	9054153440
Email	RBAKER@DIROSTECH.COM
Phone	9054153440
Email	RBAKER@DIROSTECH.COM
Phone	9054153440
Email	RBAKER@DIROSTECH.COM
Phone	9054153440
Email	RBAKER@DIROSTECH.COM
Phone	9054153440
Email	RBAKER@DIROSTECH.COM
Phone	9054153440
Email	RBAKER@DIROSTECH.COM
Phone	9054153440
Email	RBAKER@DIROSTECH.COM
Phone	9054153440
Email	RBAKER@DIROSTECH.COM
Phone	9054153440
Email	RBAKER@DIROSTECH.COM
Phone	9054153440
Email	RBAKER@DIROSTECH.COM
Phone	9054153440
Email	RBAKER@DIROSTECH.COM
Phone	9054153440
Email	RBAKER@DIROSTECH.COM
Phone	9054153440
Email	RBAKER@DIROSTECH.COM
Phone	9054153440
Email	RBAKER@DIROSTECH.COM
Phone	9054153440
Email	RBAKER@DIROSTECH.COM
Phone	9054153440
Email	RBAKER@DIROSTECH.COM
Phone	9054153440
Email	RBAKER@DIROSTECH.COM
Phone	9054153440
Email	RBAKER@DIROSTECH.COM
Phone	9054153440
Email	RBAKER@DIROSTECH.COM

Operating and Storage Conditions

Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Cool Dry Place, Away from Extreme Temperature, Humidity and Direct Sunlight
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Cool Dry Place, Away from Extreme Temperature, Humidity and Direct Sunlight
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Cool Dry Place, Away from Extreme Temperature, Humidity and Direct Sunlight
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Cool Dry Place, Away from Extreme Temperature, Humidity and Direct Sunlight
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Cool Dry Place, Away from Extreme Temperature, Humidity and Direct Sunlight
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Cool Dry Place, Away from Extreme Temperature, Humidity and Direct Sunlight
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Cool Dry Place, Away from Extreme Temperature, Humidity and Direct Sunlight
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Cool Dry Place, Away from Extreme Temperature, Humidity and Direct Sunlight
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Cool Dry Place, Away from Extreme Temperature, Humidity and Direct Sunlight
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Cool Dry Place, Away from Extreme Temperature, Humidity and Direct Sunlight
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Cool Dry Place, Away from Extreme Temperature, Humidity and Direct Sunlight
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Cool Dry Place, Away from Extreme Temperature, Humidity and Direct Sunlight
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Cool Dry Place, Away from Extreme Temperature, Humidity and Direct Sunlight
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Cool Dry Place, Away from Extreme Temperature, Humidity and Direct Sunlight
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Cool Dry Place, Away from Extreme Temperature, Humidity and Direct Sunlight
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Cool Dry Place, Away from Extreme Temperature, Humidity and Direct Sunlight
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Cool Dry Place, Away from Extreme Temperature, Humidity and Direct Sunlight
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Cool Dry Place, Away from Extreme Temperature, Humidity and Direct Sunlight
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Cool Dry Place, Away from Extreme Temperature, Humidity and Direct Sunlight
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Cool Dry Place, Away from Extreme Temperature, Humidity and Direct Sunlight
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00825114001664 [Primary]
GS1	00825114003064 [Package] Contains: 00825114001664 Package: Box [10 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K062758

FDA Product Code

GXI	Probe, Radiofrequency Lesion

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2016-09-01

On-Brand Devices [OWL]

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