Classic Stepper 642-316

GUDID 00841436105774

For use with GE Healthcare ERB transducers

CIVCO MEDICAL INSTRUMENTS CO., INC.

Prostate brachytherapy system applicator, manual
Primary Device ID00841436105774
NIH Device Record Keye0cdf845-492e-4884-9ab5-f2ebe991aca2
Commercial Distribution StatusIn Commercial Distribution
Brand NameClassic Stepper
Version Model Number642-316
Catalog Number642-316
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

Device Dimensions

Width6.22 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100841436105774 [Primary]
GS120841436117863 [Direct Marking]

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 Number4
Public Version Date2018-09-24
Device Publish Date2017-08-22

On-Brand Devices [Classic Stepper]

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00841436111454For use with Esaote TRT33 transducers
00841436107266For use with Siemens Endo-PII transducers
00841436105835For use with Hitachi Aloka Medical C41L47RP and EUP-U533 transducers
00841436105774For use with GE Healthcare ERB transducers
00841436105262For use with BK Medical 8658(8558), 8848 and E14CL4b transducers
00841436105101For use with Hitachi Aloka Medical UST-672-5/7.5 transducers
00841436101233For use with Best® Sonalis™ TRT TriView transducers
00841436121101For use with GE E7CBL transducers

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