Multi-Purpose Workstation™ Stepper 642-510

GUDID 00841436121149

For use with GE E7C8L trasducers

CIVCO MEDICAL INSTRUMENTS CO., INC.

Prostate brachytherapy system applicator, manual
Primary Device ID00841436121149
NIH Device Record Key53c275e6-e07f-4cbf-95d9-b08fa3cd196c
Commercial Distribution StatusIn Commercial Distribution
Brand NameMulti-Purpose Workstation™ Stepper
Version Model Number642-510
Catalog Number642-510
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 Kitfalse
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
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 Identifiers

Device Issuing AgencyDevice ID
GS100841436121149 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-01
Device Publish Date2021-01-22

On-Brand Devices [Multi-Purpose Workstation™ Stepper]

20841436118587For use with Terason 8BP4 transducers
00841436107280For use with Siemens Endo-PII transducers
00841436105842For use with Hitachi Aloka Medical C41L47RP and EUP-U533 transducers
00841436105781For use with GE Healthcare ERB transducers
00841436105378For use with BK Medical 8848 and E14CL4b transducers
00841436105354For use with BK Medical 8808e, 8818 and E14C4t transducers
00841436105279For use with BK Medical 8658 (8558) and 8808 transducers
00841436105149For use with Hitachi Aloka Medical UST-672-5/7.5 transducers
00841436121149For use with GE E7C8L trasducers
00841436121187For use with BK Medical 8848, E14CL4b and Tarson 8BP4 transducers
00841436115131For use with Mindray 6LB7 transducers

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