Reusable Stainless Steel Endocavity Needle Guide

GUDID 00841912102426

Stainless Steel Reusable Endocavity Needle Guide for GE BE9C Ultrasound Transducers

PROTEK MEDICAL PRODUCTS, INC.

Nonimplantable needle guide, reusable Needle guide, reusable Needle guide, reusable Needle guide, reusable
Primary Device ID00841912102426
NIH Device Record Keya9ae3754-d379-493a-bd1e-743302d75fe2
Commercial Distribution StatusIn Commercial Distribution
Brand NameReusable Stainless Steel Endocavity Needle Guide
Version Model Number6026
Company DUNS965417181
Company NamePROTEK MEDICAL PRODUCTS, 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 Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100841912102426 [Direct Marking]
GS110841912102423 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, Ultrasonic, Diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841912102426]

Moist Heat or Steam Sterilization


[00841912102426]

Moist Heat or Steam Sterilization


[00841912102426]

Moist Heat or Steam Sterilization


[00841912102426]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-12-23
Device Publish Date2016-09-16

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00841912102631Stainless Steel Reusable Endocavity Needle Guide for GE E7C-RC Ultrasound Transducers
00841912102556Stainless Steel Reusable Endocavity Needle Guide for use with DBSE12X for Esaote EC1123, SE3133
00841912102518Stainless Steel Reusable Endocavity Needle Guide for Samsung Medison 3D5-8EK Ultrasound Transduc
00841912102457Stainless Steel Reusable Endocavity Needle Guide for B&K 8808 Ultrasound Transducers
00841912105786Stainless Steel Reusable Endocavity Needle Guide for GE IC9-RS Ultrasound Transducer
00841912105793Stainless Steel Reusable Endocavity Needle Guide for Hitachi C41V1 Ultrasound Transducers
00841912105250Stainless Steel Reusable Endocavity Needle Guide for Toshiba PVT-781VT, PVU-781VT & 11C3 Ultraso
00841912105229Stainless Steel Reusable Endocavity Needle Guide for GE RIC5-9-D, RIC5-9H, RIC5-9W-D, RIC5-9W-RS
00841912104864Stainless Steel Reusable Endocavity Needle Guide for Supersonic Imagine SE12-3
00841912104420Stainless Steel Reusable Endocavity Needle Guide for Alpinion VE3-10H Ultrasound Transducers
00841912103133Stainless Steel Reusable Endocavity Needle Guide for GE E8C/E721 Ultrasound Transducers
00841912102747Stainless Steel Reusable Endocavity Needle Guide for Toshiba PVM-651VT Ultrasound Transducers
00841912102730Stainless Steel Reusable Endocavity Needle Guide for Siemens P2 Ultrasound Transducers
00841912102723Stainless Steel Reusable Endocavity Needle Guide for Siemens P2 Ultrasound Transducers
00841912102716Stainless Steel Reusable Endocavity Needle Guide for Siemens EC9-4 Ultrasound Transducers
00841912102709Stainless Steel Reusable Endocavity Needle Guide for Siemens/Acuson EC-10C5 & EC7 and Samsung Me
00841912102693Stainless Steel Reusable Endocavity Needle Guide for Shimadzu EC11R-055U Ultrasound Transducers
00841912102655Stainless Steel Reusable Endocavity Needle Guide for Samsung Medison EV4-9/10ED, ER4-9/10ED, EC4
00841912102648Stainless Steel Reusable Endocavity Needle Guide for GE E8C/E721 Ultrasound Transducers
00841912102624Stainless Steel Reusable Endocavity Needle Guide for Philips/ATL C9-5 ICT, C9-5ec & 9-5 Endo 8,
00841912102617Stainless Steel Reusable Endocavity Needle Guide for Philips/ATL C9-5 ICT, C9-5ec & 9-5 Endo 8,
00841912102570Stainless Steel Reusable Endocavity Needle Guide for Hitachi EUP-V33, -V33W, -V53W Ultrasound Tr
00841912102563Stainless Steel Reusable Endocavity Needle Guide for Hitachi EUP-V33, -V33W, -V53W Ultrasound Tr
00841912102549Stainless Steel Reusable Endocavity Needle Guide for B&K 8667/8567S Ultrasound Transducers
00841912102532Stainless Steel Reusable Endocavity Needle Guide for GE E8C/E8C-RS/E72/E721/MTZ/MZ/IC5-9H Ultras
00841912102525Stainless Steel Reusable Endocavity Needle Guide for Zonare E9-4 Ultrasound Transducers
00841912102501Stainless Steel Reusable Endocavity Needle Guide for Samsung Medison ER4-9 Ultrasound Transducer
00841912102495Stainless Steel Reusable Endocavity Needle Guide for GE BE9C Ultrasound Transducers
00841912102488Stainless Steel Reusable Endocavity Needle Guide for GE E8C/E721 Ultrasound Transducers
00841912102471Stainless Steel Reusable Endocavity Needle Guide for GE TR7/618E Ultrasound Transducers
00841912102464Stainless Steel Reusable Endocavity Needle Guide for GE TR7/618E Ultrasound Transducers
00841912102440Stainless Steel Reusable Endocavity Needle Guide for Samsung Medison EC4-9-10ED Ultrasound Trans
00841912102433Stainless Steel Reusable Endocavity Needle Guide for Samsung Medison EC4-9ES, EC4-9IS Ultrasound
00841912102426Stainless Steel Reusable Endocavity Needle Guide for GE BE9C Ultrasound Transducers
00841912102419Stainless Steel Reusable Endocavity Needle Guide for ATL EC 6.5 Ultrasound Transducers
00841912102402Stainless Steel Reusable Endocavity Needle Guide for Shimadzu TV11R-055U Ultrasound Transducers
00841912102396Stainless Steel Reusable Endocavity Needle Guide for Shimadzu TV11R-055U Ultrasound Transducers
00841912105922Stainless Steel Reusable Endocavity Needle Guide for Samsung Medison EA2-11AR & EA2-11AV Ultraso
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