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 plastic guides for urethral injections, stainless steel 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. This is a single-use device.
GUDID devices
1,075
Last updated
2020-07-27 08:35:06

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
03665134000059Reusable guideKOELISGPK-4902020-07-17
18052286424369COXMEDAX SRL UNIPERSONALECM20200-102020-07-02
18052286424178COXMEDAX SRL UNIPERSONALECM16160-102020-05-13
18052286424185COXMEDAX SRL UNIPERSONALECM18100-102020-05-13
18052286424192COXMEDAX SRL UNIPERSONALECM18160-102020-05-13
18052286424208COXMEDAX SRL UNIPERSONALECM18200-102020-05-13
18052286424215COXMEDAX SRL UNIPERSONALECM20100-102020-05-13
18052286424222COXMEDAX SRL UNIPERSONALECM20160-102020-05-13
18052286423508COXMEDAX SRL UNIPERSONALECT16100-102020-05-06
18052286423515COXMEDAX SRL UNIPERSONALECT16160-102020-05-06
18052286423522COXMEDAX SRL UNIPERSONALECT16200-102020-05-06
18052286423539COXMEDAX SRL UNIPERSONALECT18100-102020-05-06
18052286423546COXMEDAX SRL UNIPERSONALECT18160-102020-05-06
18052286423553COXMEDAX SRL UNIPERSONALECT18200-102020-05-06
18052286423560COXMEDAX SRL UNIPERSONALECT20100-102020-05-06
18052286423577COXMEDAX SRL UNIPERSONALECT20160-102020-05-06
18052286423584COXMEDAX SRL UNIPERSONALECT20200-102020-05-06
18052286423447COXMEDAX SRL UNIPERSONALECT12100-102020-05-05
18052286423454COXMEDAX SRL UNIPERSONALECT12160-102020-05-05
18052286423461COXMEDAX SRL UNIPERSONALECT12200-102020-05-05
18052286423478COXMEDAX SRL UNIPERSONALECT14100-102020-05-05
18052286423485COXMEDAX SRL UNIPERSONALECT14160-102020-05-05
18052286423492COXMEDAX SRL UNIPERSONALECT14200-102020-05-05
18052286423607COXMEDAX SRL UNIPERSONALECO18100-102020-05-05
18052286423669COXMEDAX SRL UNIPERSONALECO20160-102020-05-05
18052286423676COXMEDAX SRL UNIPERSONALECO20200-102020-05-05
16971554725019InnoFineJingFang Precision Medical Device(Shenzhen) Co., Ltd.DE-0012020-04-27
16971554725026InnoFineJingFang Precision Medical Device(Shenzhen) Co., Ltd.DE-0022020-04-27
16971554725033InnoFineJingFang Precision Medical Device(Shenzhen) Co., Ltd.DE-0032020-04-27
16971554725040InnoFineJingFang Precision Medical Device(Shenzhen) Co., Ltd.DE-0042020-04-27
16971554725057InnoFineJingFang Precision Medical Device(Shenzhen) Co., Ltd.DE-0052020-04-27
16971554725064InnoFineJingFang Precision Medical Device(Shenzhen) Co., Ltd.DE-0062020-04-27
16971554725088InnoFineJingFang Precision Medical Device(Shenzhen) Co., Ltd.DE-0082020-04-27
16971554725095InnoFineJingFang Precision Medical Device(Shenzhen) Co., Ltd.DE-0092020-04-27
16971554725101InnoFineJingFang Precision Medical Device(Shenzhen) Co., Ltd.DE-0102020-04-27
16971554725118InnoFineJingFang Precision Medical Device(Shenzhen) Co., Ltd.DE-0112020-04-27
16971554725125InnoFineJingFang Precision Medical Device(Shenzhen) Co., Ltd.DE-0122020-04-27
16971554725132InnoFineJingFang Precision Medical Device(Shenzhen) Co., Ltd.DE-0132020-04-27
16971554725149InnoFineJingFang Precision Medical Device(Shenzhen) Co., Ltd.DE-0142020-04-27
16971554725156InnoFineJingFang Precision Medical Device(Shenzhen) Co., Ltd.DE-0152020-04-27
16971554725163InnoFineJingFang Precision Medical Device(Shenzhen) Co., Ltd.DE-0162020-04-27
16971554725170InnoFineJingFang Precision Medical Device(Shenzhen) Co., Ltd.DE-0172020-04-27
16971554725187InnoFineJingFang Precision Medical Device(Shenzhen) Co., Ltd.DE-0182020-04-27
16971554725194InnoFineJingFang Precision Medical Device(Shenzhen) Co., Ltd.DE-0192020-04-27
16971554725200InnoFineJingFang Precision Medical Device(Shenzhen) Co., Ltd.DE-0202020-04-27
16971554725217InnoFineJingFang Precision Medical Device(Shenzhen) Co., Ltd.DE-0212020-04-27
00884838081765InvivoPhilips DS North America LLC4535-302-233112020-04-17
00884838081772InvivoPhilips DS North America LLC4535-302-581212020-04-17
00884838081789InvivoPhilips DS North America LLC4535-303-129312020-04-17
00884838081796InvivoPhilips DS North America LLC4535-303-249212020-04-17
00884838081802InvivoPhilips DS North America LLC4535-303-323612020-04-17
00884838081819InvivoPhilips DS North America LLC4535-303-388312020-04-17
00884838100114InvivoPhilips DS North America LLC4535-302-233312020-04-17
00815568021226Kobold® Prostate HDR Stepper Template - 17 ga/4 FrKOBOLD, LLC812-0002019-11-20
00815568021233Kobold® Prostate HDR Stepper Template - 16 ga/5 FrKOBOLD, LLC811-0002019-11-20
00815568021240Kobold® Prostate HDR Template - 18 gaKOBOLD, LLC804-0002019-11-20
00815568021257Kobold® Prostate HDR Template - 17 ga/4 FrKOBOLD, LLC803-0002019-11-20
00815568021264Kobold® Prostate HDR Template - 16 ga/5 FrKOBOLD, LLC802-0002019-11-20
10841912105707Sterile Disposable Endocavity Needle Guide KitPROTEK MEDICAL PRODUCTS, INC.52672020-03-13
10841912106162Sterile Disposable Endocavity Needle Guide KitPROTEK MEDICAL PRODUCTS, INC.53732020-03-13
10841912106308Sterile Disposable Endocavity Needle GuidePROTEK MEDICAL PRODUCTS, INC.53902020-03-13
10841912106346Sterile Disposable Endocavity Needle Guide KitPROTEK MEDICAL PRODUCTS, INC.55352020-03-13
10841912106384Sterile Disposable Endocavity Needle GuidePROTEK MEDICAL PRODUCTS, INC.56652020-03-13
10841912106469Sterile Disposable Endocavity Needle Guide KitPROTEK MEDICAL PRODUCTS, INC.53882020-03-13
00841912106455Disposable Needle GuidePROTEK MEDICAL PRODUCTS, INC.54452020-03-13
M710ERGUIDE1010OcciGuideBIOTEX, INC.ER GUIDE 10102020-02-20
18052283959116COXMEDAX SRL UNIPERSONALECO18200-102020-01-30
00815568020892Kobold® Prostate HDR Stepper Template - 6 FrKOBOLD, LLC813-0002019-12-09
07290015487115Introducer D2.5 mm, 115 mm, Trocar. ICECURE MEDICAL LTDFAC90000002019-10-24
07290015487122Introducer D3.5 mm, 122 mm, Trocar. ICECURE MEDICAL LTDFAC91000002019-10-24
07290015487139Introducer D3.5 mm, 167 mm, Trocar. ICECURE MEDICAL LTDFAC92000002019-10-24
18052283955668COX for MEDONEMEDAX SRL UNIPERSONALECO18160-102019-10-02
18052283955675COX for MEDONEMEDAX SRL UNIPERSONALECO20100-102019-10-02
04260277171407Coaxial needleMöller Medical GmbHCOX-1010-20-00492018-08-17
04260277171414Coaxial needleMöller Medical GmbHCOX-1010-20-01092018-08-17
04260277171421Coaxial needleMöller Medical GmbHCOX-1010-18-00462018-08-17
04260277171438Coaxial needleMöller Medical GmbHCOX-1010-18-01062018-08-17
04260277171445Coaxial needleMöller Medical GmbHCOX-1010-18-01462018-08-17
04260277171452Coaxial needleMöller Medical GmbHCOX-1010-16-00462018-08-17
04260277171469Coaxial needleMöller Medical GmbHCOX-1010-16-01062018-08-17