AccuSITE Needle Guide 610-1017, 610-1030, 610-1123

GUDID 00841436102131

Sterile needle guide with (14 x 147cm) telescopically-folded CIV-Flex™ cover

CIVCO MEDICAL INSTRUMENTS CO., INC.

Nonimplantable needle guide, single-use

• Primary Device ID: 00841436102131
• NIH Device Record Key: 167ece4d-91a1-425d-87a9-2d967763af3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccuSITE Needle Guide
• Version Model Number: 610-1017, 610-1030, 610-1123
• Catalog Number: 610-1017, 610-1030, 610-1123
• Company DUNS: 134614411
• Company Name: CIVCO MEDICAL INSTRUMENTS CO., INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com

Device Dimensions

• Length: 5.5 Inch
• Width: 3.3 Inch
• Length: 5.5 Inch
• Width: 3.3 Inch
• Length: 5.5 Inch
• Width: 3.3 Inch
• Length: 5.5 Inch
• Width: 3.3 Inch
• Length: 5.5 Inch
• Width: 3.3 Inch
• Length: 5.5 Inch
• Width: 3.3 Inch
• Length: 5.5 Inch
• Width: 3.3 Inch
• Length: 5.5 Inch
• Width: 3.3 Inch
• Length: 5.5 Inch
• Width: 3.3 Inch
• Length: 5.5 Inch
• Width: 3.3 Inch
• Length: 5.5 Inch
• Width: 3.3 Inch
• Length: 5.5 Inch
• Width: 3.3 Inch
• Length: 5.5 Inch
• Width: 3.3 Inch
• Length: 5.5 Inch

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841436101646 [Package]; Contains: 10841436101643; Package: [24 Units]; In Commercial Distribution
GS1	00841436101738 [Package]; Contains: 00841436101646; Package: [5 Units]; In Commercial Distribution
GS1	00841436102131 [Package]; Contains: 00841436101738; Package: [12 Units]; In Commercial Distribution
GS1	10841436101643 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093713

FDA Product Code

• ITX: Transducer, ultrasonic, diagnostic

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[00841436102131]

Ethylene Oxide

[00841436102131]

Ethylene Oxide

[00841436102131]

Ethylene Oxide

[00841436102131]

Ethylene Oxide

[00841436102131]

Ethylene Oxide

[00841436102131]

Ethylene Oxide

[00841436102131]

Ethylene Oxide

[00841436102131]

Ethylene Oxide

[00841436102131]

Ethylene Oxide

[00841436102131]

Ethylene Oxide

[00841436102131]

Ethylene Oxide

[00841436102131]

Ethylene Oxide

[00841436102131]

Ethylene Oxide

[00841436102131]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-07
• Device Publish Date: 2017-08-22

On-Brand Devices [AccuSITE Needle Guide]

• 00841436102568: Sterile needle guide with (14 x 29.2cm) telescopically-folded CIV-Flex™ wireless transducer co
• 00841436102551: Sterile needle guide with (14 x 29.2cm) telescopically-folded CIV-Flex™ wireless transducer co
• 00841436102506: Sterile needle guide with (14 x 29.2cm) telescopically-folded CIV-Flex™ wireless transducer co
• 00841436102155: Sterile needle guide with (14 x 147cm) telescopically-folded CIV-Flex™ cover
• 00841436101653: Sterile needle guide with (14 x 147cm) telescopically-folded CIV-Flex™ cover
• 00841436102131: Sterile needle guide with (14 x 147cm) telescopically-folded CIV-Flex™ cover
• 00841436101752: Sterile needle guide with (14 x 147cm) telescopically-folded CIV-Flex™ cover
• 00841436101738: Sterile needle guide with (14 x 147cm) telescopically-folded CIV-Flex™ cover