OWL 467-022/100/10-BC

GUDID 00825114004160

OWL STERILE SINGLE USE DISPOSABLE BLUNT CURVED RF INSULATED CANNULA (22 Ga.), 100mm LONG, 10MM BARE TIP

Diros Technology Inc

Radio-frequency ablation system probe cannula, single-use

• Primary Device ID: 00825114004160
• NIH Device Record Key: 765f12cb-7a6c-4ecc-a230-e6178af57c8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OWL
• Version Model Number: 467-022/100/10-BC
• Catalog Number: 467-022/100/10-BC
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00825114004153 [Primary]
GS1	00825114004160 [Package]; Contains: 00825114004153; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102566

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,