Endocavity Balloon UA0059

GUDID 00841436110280

Non-sterile (2 x 14cm) endocavity balloon for use with BK Medical 8658 (8558), 8848 and E14CL4b transducers

CIVCO MEDICAL INSTRUMENTS CO., INC.

Body-orifice ultrasound imaging transducer cover, image-enhancement
Primary Device ID00841436110280
NIH Device Record Keyd4895d4c-8070-4a69-932c-5cf47302d08e
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndocavity Balloon
Version Model NumberUA0059
Catalog NumberUA0059
Company DUNS134614411
Company NameCIVCO MEDICAL INSTRUMENTS CO., INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
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

Device Dimensions

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
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
GS100841436110280 [Package]
Contains: 10841436110287
Package: [10 Units]
In Commercial Distribution
GS110841436110287 [Primary]

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 Number5
Public Version Date2021-09-06
Device Publish Date2017-08-22

On-Brand Devices [Endocavity Balloon]

00841436109079Non-sterile (2 x 14cm) endocavity balloon for use with B-K Medical 8658 (8558) and 8848, Best®
00841436110280Non-sterile (2 x 14cm) endocavity balloon for use with BK Medical 8658 (8558), 8848 and E14CL4b
00841436104319Non-sterile (2 x 14cm) endocavity balloon for use with AccuCARE Positioning and Stabilizing equi
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