Classic Stepper 609-001

GUDID 00841436101233

For use with Best® Sonalis™ TRT TriView transducers

CIVCO MEDICAL INSTRUMENTS CO., INC.

Prostate brachytherapy system applicator, manual
Primary Device ID00841436101233
NIH Device Record Keye7920004-b0af-4733-868b-2ca7afe26e9d
Commercial Distribution StatusIn Commercial Distribution
Brand NameClassic Stepper
Version Model Number609-001
Catalog Number609-001
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

Length15.97 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100841436101233 [Primary]
GS120841436117832 [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]

00841436108768For use with GE Healthcare ERB transducers
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.