AccuCARE Accessory Kit 610-1293

GUDID 00841436103022

Sterile 18GA grid (10), sterile (81.3 x 91.4cm) polyethylene drape (10), non-sterile (2 x 14cm) endocavity balloon (10) and sterile Aquasonic 20 gram gel packettes (10)

CIVCO MEDICAL INSTRUMENTS CO., INC.

Manual brachytherapy system

• Primary Device ID: 00841436103022
• NIH Device Record Key: c01de66a-822a-43c1-80db-c48511ab5dec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccuCARE Accessory Kit
• Version Model Number: 610-1293
• Catalog Number: 610-1293
• Company DUNS: 134614411
• Company Name: CIVCO MEDICAL INSTRUMENTS CO., INC.
• Device Count: 10
• 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
• 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

• 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
• Width: 3.2 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	00841436103022 [Primary]
GS1	80841436103028 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131161

FDA Product Code

• JAQ: System, applicator, radionuclide, remote-controlled

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

On-Brand Devices [AccuCARE Accessory Kit]

• 00841436103046: Sterile 17GA grid (10), sterile (81.3 x 91.4cm) polyethylene drape (10), non-sterile (2 x 14cm)
• 00841436103022: Sterile 18GA grid (10), sterile (81.3 x 91.4cm) polyethylene drape (10), non-sterile (2 x 14cm)