Cradle 609-003

GUDID 00841436101240

For use with 3G Ultrasound SimulView Classic Stepper

CIVCO MEDICAL INSTRUMENTS CO., INC.

Prostate brachytherapy system applicator, manual
Primary Device ID00841436101240
NIH Device Record Key4666a283-08f0-42fc-bfcf-4df4cd27755a
Commercial Distribution StatusIn Commercial Distribution
Brand NameCradle
Version Model Number609-003
Catalog Number609-003
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
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

Device Dimensions

Width6.3 Centimeter
Length11.9 Centimeter
Width6.3 Centimeter
Length11.9 Centimeter
Width6.3 Centimeter
Length11.9 Centimeter
Width6.3 Centimeter
Length11.9 Centimeter
Width6.3 Centimeter
Length11.9 Centimeter
Width6.3 Centimeter
Length11.9 Centimeter
Width6.3 Centimeter
Length11.9 Centimeter
Width6.3 Centimeter
Length11.9 Centimeter
Width6.3 Centimeter
Length11.9 Centimeter
Width6.3 Centimeter

Operating and Storage Conditions

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
GS100841436101240 [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 Number3
Public Version Date2018-07-06
Device Publish Date2017-08-22

On-Brand Devices [Cradle]

00841436118545For use with Sonoscape BCL10-5 Multi-Purpose Workstations Steppers
00841436118460For use with Terason 8BP4 Multi-Purpose Workstation™ Steppers
00841436111638For use with Siemens Endo-PII EXII/EX3 Stepper
00841436111621For use with Siemens Endo-PII Workstation Stepper
00841436111560For use with Hitachi Aloka Medical C41L47RP and EUP-U533 EXII/EX3 Steppers
00841436111553For use with Hitachi Aloka Medical UST-672-5/7.5 EXII/EX3 Steppers
00841436111546For use with Hitachi Aloka Medical EUP-U533 and C41L47RP Workstation Steppers
00841436111539For use with Hitachi Aloka Medical UST-672-5/7.5 Workstation Steppers
00841436111515For use with GE healthcare ERB EXII/EX3 Stepper
00841436111508For use with GE healthcare ERB Workstation Stepper
00841436111423For use with BK Medical 8558, 8658, and 8848 EXII/EX3 Steppers
00841436111416For use with BK Medical 8848 and E14CL4b Workstation Steppers
00841436111409For use with BK Medical 8558, 8658, and 8808 Workstation Steppers
00841436111393For use with BK Medical 8808e and 8818 Workstation Steppers
00841436111164For use with Terason 8B4S EXII/EX3 Stepper
00841436111157For use with Best® Sonalis™ TRT TriView EXII/EX3 Stepper
00841436107341For use with Siemens Endo-P II Classic Stepper
00841436105804For use with GE Healthcare ERB Classic Stepper
00841436105347For use with BK Medical 8658(8558), 8848 and E14CL4b Classic Stepper
00841436101240For use with 3G Ultrasound SimulView Classic Stepper
00841436121132For use with GE E7C8L Steppers
00841436121118For use with GE E7C8L EX3 Stepper
00841436121095For use with GE E7C8L Classic Steppers
00841436115124For use with Mindray 6LB7s Multi-Purpose Workstation Stepper
00841436121545For use with Mindray ELC13-4U/E/s EX3™ Stepper
00841436114295For use with Exact Imaging EV29L Multi-Purpose Workstation™ Stepper

Trademark Results [Cradle]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CRADLE
CRADLE
98109480 not registered Live/Pending
CACI International Inc
2023-07-31
CRADLE
CRADLE
98109473 not registered Live/Pending
CACI International Inc
2023-07-31
CRADLE
CRADLE
98050320 not registered Live/Pending
Case Western Reserve University
2023-06-20
CRADLE
CRADLE
97012605 not registered Live/Pending
CACI International Inc
2021-09-04
CRADLE
CRADLE
97012604 not registered Live/Pending
CACI International Inc
2021-09-04
CRADLE
CRADLE
87113498 5302873 Live/Registered
Baby Bugs LLC
2016-07-22
CRADLE
CRADLE
86936880 5032015 Live/Registered
Software Cradle Co., Ltd.
2016-03-11
CRADLE
CRADLE
86920460 5054300 Live/Registered
Baby Bugs LLC
2016-02-25
CRADLE
CRADLE
86482262 5020094 Live/Registered
Case Western Reserve University
2014-12-16
CRADLE
CRADLE
86259988 5055040 Live/Registered
The North Face Apparel Corp
2014-04-23
CRADLE
CRADLE
86254597 4857038 Live/Registered
The North Face Apparel Corp
2014-04-17
CRADLE
CRADLE
85975250 not registered Dead/Abandoned
LG Electronics Inc.
2010-07-30

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