EX3 Stepper 609-004

GUDID 00841436101257

For use with Best® Sonalis™ TRT TriView transducers

CIVCO MEDICAL INSTRUMENTS CO., INC.

Manual brachytherapy system
Primary Device ID00841436101257
NIH Device Record Key1eceb11f-600d-4135-bd9a-279c5bbd7093
Commercial Distribution StatusIn Commercial Distribution
Brand NameEX3 Stepper
Version Model Number609-004
Catalog Number609-004
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 Numbertrue
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

Length44.1 Centimeter
Length15.97 Inch
Width6.21 Inch
Length15.97 Inch
Width6.21 Inch
Length15.97 Inch
Width6.21 Inch
Length15.97 Inch
Width6.21 Inch
Length15.97 Inch
Width6.21 Inch
Length15.97 Inch
Width6.21 Inch
Length15.97 Inch
Width6.21 Inch
Length15.97 Inch
Width6.21 Inch
Length15.97 Inch
Width6.21 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100841436101257 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IWJSystem, applicator, radionuclide, manual

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 [EX3 Stepper]

00841436107839For use with Terason 8B4S transducers
00841436107396For use with Siemens Endo-PII transducers
00841436105972For use with Hitachi Aloka Medical C41L47RP and EUP-U533 transducers
00841436105811For use with GE ERB transducers
00841436105392EX3 Stepper
00841436105255For use with Hitachi Aloka Medical UST-672-5/7.5 transducers
00841436101257For use with Best® Sonalis™ TRT TriView transducers

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