Brachytherapy Kit 3 610-1295-5

GUDID 00841436103053

Sterile (81.3 x 91.4cm) polyethylene drape (2), non-sterile (2 x 14cm) endocavity balloon (2) for use with AccuCARE Positioning and Stabilizing equipment

CIVCO MEDICAL INSTRUMENTS CO., INC.

Body-orifice ultrasound imaging transducer cover, image-enhancement Body-orifice ultrasound imaging transducer cover, image-enhancement Body-orifice ultrasound imaging transducer cover, image-enhancement Body-orifice ultrasound imaging transducer cover, image-enhancement Body-orifice ultrasound imaging transducer cover, image-enhancement Body-orifice ultrasound imaging transducer cover, image-enhancement Body-orifice ultrasound imaging transducer cover, image-enhancement Body-orifice ultrasound imaging transducer cover, image-enhancement Body-orifice ultrasound imaging transducer cover, image-enhancement Body-orifice ultrasound imaging transducer cover, image-enhancement Body-orifice ultrasound imaging transducer cover, image-enhancement Body-orifice ultrasound imaging transducer cover, image-enhancement Body-orifice ultrasound imaging transducer cover, image-enhancement Body-orifice ultrasound imaging transducer cover, image-enhancement Body-orifice ultrasound imaging transducer cover, image-enhancement Body-orifice ultrasound imaging transducer cover, image-enhancement Body-orifice ultrasound imaging transducer cover, image-enhancement Body-orifice ultrasound imaging transducer cover, image-enhancement Body-orifice ultrasound imaging transducer cover, image-enhancement Body-orifice ultrasound imaging transducer cover, image-enhancement Body-orifice ultrasound imaging transducer cover, image-enhancement Body-orifice ultrasound imaging transducer cover, image-enhancement Body-orifice ultrasound imaging transducer cover, image-enhancement Body-orifice ultrasound imaging transducer cover, image-enhancement
Primary Device ID00841436103053
NIH Device Record Keyc84b710c-0e35-4fa0-9a10-44c5656274ed
Commercial Distribution StatusIn Commercial Distribution
Brand NameBrachytherapy Kit 3
Version Model Number610-1295-5
Catalog Number610-1295-5
Company DUNS134614411
Company NameCIVCO MEDICAL INSTRUMENTS CO., INC.
Device Count2
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com

Device Dimensions

Lumen/Inner Diameter0.83 Inch
Length7.5 Inch
Lumen/Inner Diameter0.83 Inch
Length7.5 Inch
Lumen/Inner Diameter0.83 Inch
Length7.5 Inch
Lumen/Inner Diameter0.83 Inch
Length7.5 Inch
Lumen/Inner Diameter0.83 Inch
Length7.5 Inch
Lumen/Inner Diameter0.83 Inch
Length7.5 Inch
Lumen/Inner Diameter0.83 Inch
Length7.5 Inch
Lumen/Inner Diameter0.83 Inch
Length7.5 Inch
Lumen/Inner Diameter0.83 Inch
Length7.5 Inch
Lumen/Inner Diameter0.83 Inch
Length7.5 Inch
Lumen/Inner Diameter0.83 Inch
Length7.5 Inch
Lumen/Inner Diameter0.83 Inch
Length7.5 Inch
Lumen/Inner Diameter0.83 Inch
Length7.5 Inch
Lumen/Inner Diameter0.83 Inch
Length7.5 Inch
Lumen/Inner Diameter0.83 Inch
Length7.5 Inch
Lumen/Inner Diameter0.83 Inch
Length7.5 Inch
Lumen/Inner Diameter0.83 Inch
Length7.5 Inch
Lumen/Inner Diameter0.83 Inch
Length7.5 Inch
Lumen/Inner Diameter0.83 Inch
Length7.5 Inch
Lumen/Inner Diameter0.83 Inch
Length7.5 Inch
Lumen/Inner Diameter0.83 Inch
Length7.5 Inch
Lumen/Inner Diameter0.83 Inch
Length7.5 Inch
Lumen/Inner Diameter0.83 Inch
Length7.5 Inch
Lumen/Inner Diameter0.83 Inch

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100841436103053 [Primary]
GS180841436103059 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2017-08-22

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