Brachytherapy Kit 1 610-1293-5

GUDID 00841436103015

Sterile 18GA grid (2), sterile (81.3 x 91.4cm) polyethylene drape (2), non-sterile (2 x 14cm) endocavity balloon (2) for use with AccuCARE Positioning and Stabilizing equipment

CIVCO MEDICAL INSTRUMENTS CO., INC.

Manual brachytherapy system

• Primary Device ID: 00841436103015
• NIH Device Record Key: d0de7a6a-a650-45bd-b3cf-3293766a30a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Brachytherapy Kit 1
• Version Model Number: 610-1293-5
• Catalog Number: 610-1293-5
• Company DUNS: 134614411
• Company Name: CIVCO MEDICAL INSTRUMENTS CO., INC.
• Device Count: 2
• 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: false
• 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
• 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: 3.5 Inch
• Width: 3.2 Inch
• Length: 3.5 Inch
• Width: 3.2 Inch
• Length: 3.5 Inch
• Width: 3.2 Inch
• Length: 3.5 Inch
• Width: 3.2 Inch
• Length: 3.5 Inch
• Width: 3.2 Inch
• Length: 3.5 Inch
• Width: 3.2 Inch
• Length: 3.5 Inch
• Width: 3.2 Inch
• Length: 3.5 Inch
• Width: 3.2 Inch
• Length: 3.5 Inch
• Width: 3.2 Inch
• Length: 3.5 Inch
• Width: 3.2 Inch
• Length: 3.5 Inch
• Width: 3.2 Inch
• Length: 3.5 Inch
• Width: 3.2 Inch
• Length: 3.5 Inch
• Width: 3.2 Inch
• Length: 3.5 Inch
• Width: 3.2 Inch
• Length: 3.5 Inch
• Width: 3.2 Inch
• Length: 3.5 Inch
• Width: 3.2 Inch
• Length: 3.5 Inch
• Width: 3.2 Inch
• Length: 3.5 Inch
• Width: 3.2 Inch
• Length: 3.5 Inch
• Width: 3.2 Inch
• Length: 3.5 Inch
• Width: 3.2 Inch
• Length: 3.5 Inch
• Width: 3.2 Inch
• Length: 3.5 Inch
• Width: 3.2 Inch
• Length: 3.5 Inch
• Width: 3.2 Inch
• Length: 3.5 Inch

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841436103015 [Primary]
GS1	80841436103011 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131161

FDA Product Code

• ITX: Transducer, ultrasonic, diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-08-22

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