FDA.reportPublic FDA data

Nonimplantable needle guide, single-use

Definition
A rigid, non-powered device designed to lead a needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for many different procedures such as guides for urethral injections, guides for transrectal prostate biopsy, image-guided (e.g., ultrasound, MRI) for percutaneous punctures and nerve blocks, guides for electromagnetic device tracking systems, and guides for stereotactic breast biopsies. Disposable imaging-supportive devices (e.g., ultrasound transducer cover/gel) may be included with the device. This is a single-use device.
GUDID devices
157
Last updated
2022-05-04 08:03:19

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
M7525250240STRADIS STRADIS MEDICAL, LLC525-0242022-04-26
10841912107107Sterile Disposable Endocavity Needle GuidePROTEK MEDICAL PRODUCTS, INC.54552022-04-01
08681672050016GTK Disposable Needle GuidesGEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETIGTK1002022-03-01
08681672050023GTK Disposable Needle GuidesGEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETIGTK1012022-03-01
08681672050030GTK Disposable Needle GuidesGEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETIGTK1102022-03-01
08681672050047GTK Disposable Needle GuidesGEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETIGTK1222022-03-01
08681672050054GTK Disposable Needle GuidesGEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETIGTK1302022-03-01
08681672050061GTK Disposable Needle GuidesGEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETIGTK1402022-03-01
08681672052904GTK Disposable Needle GuidesGEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETIGTK11-R2022-03-01
08681672052911GTK Disposable Needle GuidesGEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETIGTK132022-03-01
08681672052928GTK Disposable Needle GuidesGEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETIGTK142022-03-01
08681672052935GTK Disposable Needle GuidesGEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETIGTK152022-03-01
08681672052942GTK Disposable Needle GuidesGEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETIGTK162022-03-01
08681672052959GTK Disposable Needle GuidesGEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETIGTK1202022-03-01
08681672052966GTK Disposable Needle GuidesGEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETIGTK1412022-03-01
08681672053062GTK Disposable Needle GuidesGEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETIGTK182022-03-01
08683255231843GTK Disposable Needle GuidesGEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETIGTK08-R2022-03-01
08683255231867GTK Disposable Needle GuidesGEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETIGTK09-S2022-03-01
08683255232147GTK Disposable Needle GuidesGEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETIGTK1502022-03-01
08699158340018GTK Disposable Needle GuidesGEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETIGTK012022-03-01
08699158340025GTK Disposable Needle GuidesGEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETIGTK022022-03-01
08699158340032GTK Disposable Needle GuidesGEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETIGTK032022-03-01
08699158340049GTK Disposable Needle GuidesGEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETIGTK042022-03-01
08699158340056GTK Disposable Needle GuidesGEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETIGTK052022-03-01
08699158340063GTK Disposable Needle GuidesGEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETIGTK062022-03-01
08699158340070GTK Disposable Needle GuidesGEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETIGTK072022-03-01
08699158340087GTK Disposable Needle GuidesGEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETIGTK082022-03-01
08699158340094GTK Disposable Needle GuidesGEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETIGTK092022-03-01
08699158340100GTK Disposable Needle GuidesGEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETIGTK102022-03-01
08699158340117GTK Disposable Needle GuidesGEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETIGTK112022-03-01
08699158340124GTK Disposable Needle GuidesGEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETIGTK122022-03-01
10841911100772Mammotome revolveDEVICOR MEDICAL PRODUCTS, INC.MG08A2022-02-04
10841911100789Mammotome revolveDEVICOR MEDICAL PRODUCTS, INC.MG08B2022-02-04
10841911100796Mammotome revolveDEVICOR MEDICAL PRODUCTS, INC.MG10A2022-02-04
10841911100802Mammotome revolveDEVICOR MEDICAL PRODUCTS, INC.MG10B2022-02-04
10841911101120MammotomeDEVICOR MEDICAL PRODUCTS, INC.G011F2022-02-04
10841911101137MammotomeDEVICOR MEDICAL PRODUCTS, INC.G011LF2022-02-04
10841911101144MammotomeDEVICOR MEDICAL PRODUCTS, INC.G014F2022-02-04
10841911101151MammotomeDEVICOR MEDICAL PRODUCTS, INC.G014LF2022-02-04
10841911101168MammotomeDEVICOR MEDICAL PRODUCTS, INC.G014U2022-02-04
10841911101175MammotomeDEVICOR MEDICAL PRODUCTS, INC.G020F2022-02-04
10841911101182MammotomeDEVICOR MEDICAL PRODUCTS, INC.G08LF2022-02-04
10841911101199MammotomeDEVICOR MEDICAL PRODUCTS, INC.G08U2022-02-04
08800142915079Moving-Shot GuideRF Medical Co.,Ltd.NGL18-A2-L3-12H2022-01-12
00653160292985CenturionCENTURION MEDICAL PRODUCTS CORPORATIONETW2015YST2022-01-01
10653160263302CenturionCENTURION MEDICAL PRODUCTS CORPORATIONETW1825SCST2022-01-01
00841436114455Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.657-070, 657-070-52021-11-20
00841436114479Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.657-068, 657-068-52021-11-20
00841436114592Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.657-0732021-11-20
00841436118262Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.610-14292021-11-20
00841436118279Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.610-1430. 610-1430-52021-11-20
00841436118705Integrated Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.680-172, 680-172-52021-11-20
20886333001976Co-Axial Introducer NeedleARGON MEDICAL DEVICES, INC.MCXS1820MX2021-10-07
15420045514072PERLHologic, Inc.R102021-09-17
15420045514089PERLHologic, Inc.R152021-09-17
15420045514096PERLHologic, Inc.R202021-09-17
25420045514079PERLHologic, Inc.R10-52021-09-17
00841436112055Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.113361822021-09-03
00841436113670Verza Guidance SystemCIVCO MEDICAL INSTRUMENTS CO., INC.610-1502-5, 610-1502-24, 610-1502-MC2021-09-03
00841436101738AccuSITE Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.610-1017, 610-1030, 610-11232017-08-22
00841436101752AccuSITE Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.610-1019, 610-1032, 610-11252017-08-22
00841436118774Verza Guidance SystemCIVCO MEDICAL INSTRUMENTS CO., INC.610-1501-5, 610-1501-24, 610-1501-MC2019-06-21
50749756908202DeRoyalDEROYAL INDUSTRIES, INC.28-10012021-07-28
04048223113837COAXIAL-SCHLEUSEPajunk GmbH Medizintechnologie413S1501622021-07-12
04048223111949INTRODUCERPajunk GmbH Medizintechnologie021151-30L2021-07-07
04048223111956INTRODUCERPajunk GmbH Medizintechnologie021151-30M2021-07-07
04048223112021INTRODUCERPajunk GmbH Medizintechnologie021163-30L2021-07-07
00841436114578Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.657-0642021-06-23
20841436114114Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.113439972021-06-23
20841436114145Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.113361832021-06-23
20841436116798Biopsy Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.668-0012021-06-23
20841436118679Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.657-0652021-06-23
20841436120856Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.680-1772021-06-23
00841436112147Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.676-2062021-06-23
00841436114431Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.657-0722021-06-23
00841436114462Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.657-0692021-06-23
00841436114493Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.657-0672021-06-23
20886333224757Co-Axial Introducer NeedleARGON MEDICAL DEVICES, INC.MCXS1616TXM2021-06-17
20886333224764Co-Axial Introducer NeedleARGON MEDICAL DEVICES, INC.MCXS1610TXM2021-06-17
20886333224771Co-Axial Introducer NeedleARGON MEDICAL DEVICES, INC.MCXS1416TXM2021-06-17