Konica Minolta Biopsy Starter Kit 693-006

GUDID 00841436110518

Reusable non-sterile multi-angle bracket with Ultra-Pro II™ needle guides (5) and (14 × 91.5cm) CIV-Flex™ covers (5) for use with Konica Minolta L11-3 transducers

CIVCO MEDICAL INSTRUMENTS CO., INC.

Nonimplantable needle guide, single-use

Primary Device ID	00841436110518
NIH Device Record Key	c4d77596-e65c-49a5-bba7-a04a8a0b709f
Commercial Distribution Status	In Commercial Distribution
Brand Name	Konica Minolta Biopsy Starter Kit
Version Model Number	693-006
Catalog Number	693-006
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
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	3.3 Inch
Height	1.9 Inch
Length	3.3 Inch
Height	1.9 Inch
Length	3.3 Inch
Height	1.9 Inch
Length	3.3 Inch
Height	1.9 Inch
Length	3.3 Inch
Height	1.9 Inch
Length	3.3 Inch
Height	1.9 Inch
Length	3.3 Inch
Height	1.9 Inch
Length	3.3 Inch
Height	1.9 Inch
Length	3.3 Inch
Height	1.9 Inch
Length	3.3 Inch
Height	1.9 Inch
Length	3.3 Inch
Height	1.9 Inch
Length	3.3 Inch
Height	1.9 Inch
Length	3.3 Inch
Height	1.9 Inch
Length	3.3 Inch
Height	1.9 Inch
Length	3.3 Inch
Height	1.9 Inch
Length	3.3 Inch
Height	1.9 Inch
Length	3.3 Inch
Height	1.9 Inch
Length	3.3 Inch
Height	1.9 Inch
Length	3.3 Inch
Height	1.9 Inch
Length	3.3 Inch
Height	1.9 Inch
Length	3.3 Inch
Height	1.9 Inch
Length	3.3 Inch
Height	1.9 Inch
Length	3.3 Inch
Height	1.9 Inch
Length	3.3 Inch
Height	1.9 Inch
Length	3.3 Inch
Height	1.9 Inch
Length	3.3 Inch
Height	1.9 Inch
Length	3.3 Inch
Height	1.9 Inch
Length	3.3 Inch
Height	1.9 Inch
Length	3.3 Inch
Height	1.9 Inch
Length	3.3 Inch
Height	1.9 Inch
Length	3.3 Inch
Height	1.9 Inch
Length	3.3 Inch
Height	1.9 Inch
Length	3.3 Inch
Height	1.9 Inch
Length	3.3 Inch
Height	1.9 Inch
Length	3.3 Inch
Height	1.9 Inch
Length	3.3 Inch
Height	1.9 Inch
Length	3.3 Inch
Height	1.9 Inch
Length	3.3 Inch
Height	1.9 Inch
Length	3.3 Inch
Height	1.9 Inch
Length	3.3 Inch
Height	1.9 Inch
Length	3.3 Inch
Height	1.9 Inch
Length	3.3 Inch
Height	1.9 Inch
Length	3.3 Inch
Height	1.9 Inch
Length	3.3 Inch
Height	1.9 Inch
Length	3.3 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
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
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	00841436110518 [Primary]
GS1	20841436117207 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K093713

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	5
Public Version Date	2019-10-07
Device Publish Date	2017-08-22

Devices Manufactured by CIVCO MEDICAL INSTRUMENTS CO., INC.

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