Template Grid 610-977, H46222LP

GUDID 00841436104661

Sterile guide accepts 14GA instruments or 2.4mm therapeutic probes. For use with CIVCO Classic and Multi-Purpose Workstation™ Steppers

CIVCO MEDICAL INSTRUMENTS CO., INC.

Prostate brachytherapy system applicator, manual

Primary Device ID	00841436104661
NIH Device Record Key	c8f05956-da99-4333-b001-c32183a24405
Commercial Distribution Status	In Commercial Distribution
Brand Name	Template Grid
Version Model Number	610-977, H46222LP
Catalog Number	610-977, H46222LP
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	8.5 Centimeter
Length	7.3 Centimeter
Width	8.5 Centimeter
Length	7.3 Centimeter
Width	8.5 Centimeter
Length	7.3 Centimeter
Width	8.5 Centimeter
Length	7.3 Centimeter
Width	8.5 Centimeter
Length	7.3 Centimeter
Width	8.5 Centimeter
Length	7.3 Centimeter
Width	8.5 Centimeter
Length	7.3 Centimeter
Width	8.5 Centimeter
Length	7.3 Centimeter
Width	8.5 Centimeter
Length	7.3 Centimeter
Width	8.5 Centimeter
Length	7.3 Centimeter
Width	8.5 Centimeter
Length	7.3 Centimeter
Width	8.5 Centimeter
Length	7.3 Centimeter
Width	8.5 Centimeter
Length	7.3 Centimeter
Width	8.5 Centimeter
Length	7.3 Centimeter
Width	8.5 Centimeter
Length	7.3 Centimeter
Width	8.5 Centimeter
Length	7.3 Centimeter
Width	8.5 Centimeter
Length	7.3 Centimeter
Width	8.5 Centimeter
Length	7.3 Centimeter
Width	8.5 Centimeter
Length	7.3 Centimeter
Width	8.5 Centimeter
Length	7.3 Centimeter
Width	8.5 Centimeter
Length	7.3 Centimeter
Width	8.5 Centimeter
Length	7.3 Centimeter
Width	8.5 Centimeter
Length	7.3 Centimeter

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	00841436104661 [Package] Contains: 10841436104668 Package: [5 Units] In Commercial Distribution
GS1	00841436109062 [Package] Contains: 10841436104668 Package: [5 Units] In Commercial Distribution
GS1	10841436104668 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K972672

FDA Product Code

ITX	Transducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Use	true
Device Is Sterile	true

[00841436104661]

Ethylene Oxide

[00841436104661]

Ethylene Oxide

[00841436104661]

Ethylene Oxide

[00841436104661]

Ethylene Oxide

[00841436104661]

Ethylene Oxide

[00841436104661]

Ethylene Oxide

[00841436104661]

Ethylene Oxide

[00841436104661]

Ethylene Oxide

[00841436104661]

Ethylene Oxide

[00841436104661]

Ethylene Oxide

[00841436104661]

Ethylene Oxide

[00841436104661]

Ethylene Oxide

[00841436104661]

Ethylene Oxide

[00841436104661]

Ethylene Oxide

[00841436104661]

Ethylene Oxide

[00841436104661]

Ethylene Oxide

[00841436104661]

Ethylene Oxide

[00841436104661]

Ethylene Oxide

[00841436104661]

Ethylene Oxide

[00841436104661]

Ethylene Oxide

[00841436104661]

Ethylene Oxide

[00841436104661]

Ethylene Oxide

[00841436104661]

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