Template Grid 610-906, H46222LH

GUDID 00841436104364

Sterile 18GA grid for use with AccuCARE Positioning and Stabilizing equipment

CIVCO MEDICAL INSTRUMENTS CO., INC.

Prostate brachytherapy system applicator, manual

• Primary Device ID: 00841436104364
• NIH Device Record Key: 2eed66c8-9126-4345-8516-2c75d2813b07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Template Grid
• Version Model Number: 610-906, H46222LH
• Catalog Number: 610-906, H46222LH
• 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
• 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

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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841436104364 [Package]; Contains: 10841436104361; Package: [5 Units]; In Commercial Distribution
GS1	00841436109000 [Package]; Contains: 10841436104361; Package: [5 Units]; In Commercial Distribution
GS1	10841436104361 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131161

FDA Product Code

• IWJ: System, applicator, radionuclide, manual

Sterilization

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

[00841436104364]

Ethylene Oxide

[00841436104364]

Ethylene Oxide

[00841436104364]

Ethylene Oxide

[00841436104364]

Ethylene Oxide

[00841436104364]

Ethylene Oxide

[00841436104364]

Ethylene Oxide

[00841436104364]

Ethylene Oxide

[00841436104364]

Ethylene Oxide

[00841436104364]

Ethylene Oxide

[00841436104364]

Ethylene Oxide

[00841436104364]

Ethylene Oxide

[00841436104364]

Ethylene Oxide

[00841436104364]

Ethylene Oxide

[00841436104364]

Ethylene Oxide

[00841436104364]

Ethylene Oxide

[00841436104364]

Ethylene Oxide

[00841436104364]

Ethylene Oxide

[00841436104364]

Ethylene Oxide

[00841436104364]

Ethylene Oxide

[00841436104364]

Ethylene Oxide

[00841436104364]

Ethylene Oxide

[00841436104364]

Ethylene Oxide

[00841436104364]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-09-06
• Device Publish Date: 2017-08-22

On-Brand Devices [Template Grid]

• 00841436110419: Sterile 17GA grid for use with AccuCARE Positioning and Stabilizing Equipment
• 00841436110402: Sterile 18GA grid for use with AccuCARE Positioning and Stabilizing Equipment
• 00841436104661: Sterile guide accepts 14GA instruments or 2.4mm therapeutic probes. For use with CIVCO Classic a
• 00841436104364: Sterile 18GA grid for use with AccuCARE Positioning and Stabilizing equipment
• 00841436104357: Sterile 17GA grid for use with AccuCARE Positioning and Stabilizing equipment