Biopsy Bracket Starter Kit 10441189

GUDID 00841436100311

Reusable non-sterile single-angle tracking bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) CIV-Flex™ covers (5), cleaning brushes (5) for use with Siemens 6C2 transducers

CIVCO MEDICAL INSTRUMENTS CO., INC.

Ultrasound imaging system tracking holder, reusable

Primary Device ID	00841436100311
NIH Device Record Key	2216196a-f899-4973-a6b6-dec47a10b484
Commercial Distribution Status	In Commercial Distribution
Brand Name	Biopsy Bracket Starter Kit
Version Model Number	10441189
Catalog Number	10441189
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	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
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

Height	1.42 Inch
Length	3.69 Inch
Height	1.42 Inch
Length	3.69 Inch
Height	1.42 Inch
Length	3.69 Inch
Height	1.42 Inch
Length	3.69 Inch
Height	1.42 Inch
Length	3.69 Inch
Height	1.42 Inch
Length	3.69 Inch
Height	1.42 Inch
Length	3.69 Inch
Height	1.42 Inch
Length	3.69 Inch
Height	1.42 Inch
Length	3.69 Inch
Height	1.42 Inch
Length	3.69 Inch
Height	1.42 Inch
Length	3.69 Inch
Height	1.42 Inch
Length	3.69 Inch
Height	1.42 Inch
Length	3.69 Inch
Height	1.42 Inch
Length	3.69 Inch
Height	1.42 Inch
Length	3.69 Inch
Height	1.42 Inch
Length	3.69 Inch
Height	1.42 Inch
Length	3.69 Inch
Height	1.42 Inch
Length	3.69 Inch
Height	1.42 Inch
Length	3.69 Inch
Height	1.42 Inch
Length	3.69 Inch
Height	1.42 Inch
Length	3.69 Inch
Height	1.42 Inch
Length	3.69 Inch
Height	1.42 Inch
Length	3.69 Inch
Height	1.42 Inch
Length	3.69 Inch
Height	1.42 Inch
Length	3.69 Inch
Height	1.42 Inch
Length	3.69 Inch
Height	1.42 Inch
Length	3.69 Inch
Height	1.42 Inch
Length	3.69 Inch
Height	1.42 Inch
Length	3.69 Inch
Height	1.42 Inch
Length	3.69 Inch
Height	1.42 Inch
Length	3.69 Inch
Height	1.42 Inch
Length	3.69 Inch
Height	1.42 Inch
Length	3.69 Inch
Height	1.42 Inch
Length	3.69 Inch
Height	1.42 Inch
Length	3.69 Inch
Height	1.42 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
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
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	00841436100311 [Primary]
GS1	20841436116965 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K092619

FDA Product Code

IYO	System, imaging, pulsed echo, ultrasonic

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	5
Public Version Date	2019-12-23
Device Publish Date	2017-08-22

Devices Manufactured by CIVCO MEDICAL INSTRUMENTS CO., INC.

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