FDA.reportPublic FDA data

Needle guide, single-use

Definition
A rigid, non-powered device designed to direct a sharp 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 different procedures such as urethral injections, image-guided (e.g., ultrasound, MRI) transrectal/transperineal prostate biopsy or ablation, endocavity IVF procedures, percutaneous punctures, nerve blocks, electromagnetic device tracking surgery, and stereotactic breast biopsies. Procedural supportive devices (e.g., ultrasound transducer cover/sheath, drape) may be included with the device. This is a single-use device.
GUDID devices
1,272
Last updated
2026-06-11 06:06:16

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
06975122554851MindrayJingFang Precision Medical Device(Shenzhen) Co., Ltd.NGB-063-DK2026-06-02
06975122554868MindrayJingFang Precision Medical Device(Shenzhen) Co., Ltd.NGB-051-DK(17/18G)2026-06-02
06975122554875MindrayJingFang Precision Medical Device(Shenzhen) Co., Ltd.NGB-051-DK(15/16G)2026-06-02
08052283955661COX for MEDONEMEDAX SRL UNIPERSONALECO18160-102019-10-02
08052283955678COX for MEDONEMEDAX SRL UNIPERSONALECO20100-102019-10-02
08052283959119COXMEDAX SRL UNIPERSONALECO18200-102020-01-30
08052286423440COXMEDAX SRL UNIPERSONALECT12100-102020-05-05
08052286423457COXMEDAX SRL UNIPERSONALECT12160-102020-05-05
08052286423464COXMEDAX SRL UNIPERSONALECT12200-102020-05-05
08052286423471COXMEDAX SRL UNIPERSONALECT14100-102020-05-05
08052286423488COXMEDAX SRL UNIPERSONALECT14160-102020-05-05
08052286423495COXMEDAX SRL UNIPERSONALECT14200-102020-05-05
08052286423501COXMEDAX SRL UNIPERSONALECT16100-102020-05-06
08052286423518COXMEDAX SRL UNIPERSONALECT16160-102020-05-06
08052286423525COXMEDAX SRL UNIPERSONALECT16200-102020-05-06
08052286423532COXMEDAX SRL UNIPERSONALECT18100-102020-05-06
08052286423549COXMEDAX SRL UNIPERSONALECT18160-102020-05-06
08052286423556COXMEDAX SRL UNIPERSONALECT18200-102020-05-06
08052286423563COXMEDAX SRL UNIPERSONALECT20100-102020-05-06
08052286423570COXMEDAX SRL UNIPERSONALECT20160-102020-05-06
08052286423587COXMEDAX SRL UNIPERSONALECT20200-102020-05-06
08052286423600COXMEDAX SRL UNIPERSONALECO18100-102020-05-05
08052286423662COXMEDAX SRL UNIPERSONALECO20160-102020-05-05
08052286423679COXMEDAX SRL UNIPERSONALECO20200-102020-05-05
08052286424171COXMEDAX SRL UNIPERSONALECM16160-102020-05-13
08052286424188COXMEDAX SRL UNIPERSONALECM18100-102020-05-13
08052286424195COXMEDAX SRL UNIPERSONALECM18160-102020-05-13
08052286424201COXMEDAX SRL UNIPERSONALECM18200-102020-05-13
08052286424218COXMEDAX SRL UNIPERSONALECM20100-102020-05-13
08052286424225COXMEDAX SRL UNIPERSONALECM20160-102020-05-13
08052286424362COXMEDAX SRL UNIPERSONALECM20200-102020-07-02
08052286427967COXMEDAX SRL UNIPERSONALECO14100-102021-01-15
08052286428001COXMEDAX SRL UNIPERSONALECT18250-102021-01-15
08052286428186COXMEDAX SRL UNIPERSONALECM20250-102021-02-11
08053329376082COX for MEDONEMEDAX SRL UNIPERSONALECO12100-002018-03-06
08053329376105COX for MEDONEMEDAX SRL UNIPERSONALECO12160-002018-03-06
08053329376167COX for MEDONEMEDAX SRL UNIPERSONALECO14100-002018-03-06
08053329376181COX for MEDONEMEDAX SRL UNIPERSONALECO14160-002018-03-06
08053329376204COXMEDAX SRL UNIPERSONALECO14200-002019-02-13
08053329376242COX for MEDONEMEDAX SRL UNIPERSONALECO16100-002018-03-06
08053329376266COX for MEDONEMEDAX SRL UNIPERSONALECO16160-002018-03-06
08053329376280COX for MEDONEMEDAX SRL UNIPERSONALECO16200-002018-03-06
08053329376334COX for MEDONEMEDAX SRL UNIPERSONALECO18160-002018-03-06
08053329376358COX for MEDONEMEDAX SRL UNIPERSONALECO18200-002018-03-06
08053329376396COX for MEDONEMEDAX SRL UNIPERSONALECO20100-002018-03-06
08053329376419COX for MEDONEMEDAX SRL UNIPERSONALECO20160-002018-03-06
08053329376433COX for MEDONEMEDAX SRL UNIPERSONALECO20200-002018-03-06
08055002900263Velox ProMEDAX SRL UNIPERSONALEVP14060-002016-09-21
08055002900270Velox ProMEDAX SRL UNIPERSONALEVP14100-002016-09-21
08055002900287Velox ProMEDAX SRL UNIPERSONALEVP14100-C02016-09-21
08055002900294Velox ProMEDAX SRL UNIPERSONALEVP14160-002016-09-21
08055002900300Velox ProMEDAX SRL UNIPERSONALEVP14160-C02016-09-21
08055002900317Velox ProMEDAX SRL UNIPERSONALEVP14200-002016-09-21
08055002900324Velox ProMEDAX SRL UNIPERSONALEVP14200-C02016-09-21
08055002900331Velox ProMEDAX SRL UNIPERSONALEVP16100-002016-09-21
08055002900348Velox ProMEDAX SRL UNIPERSONALEVP16100-C02016-09-21
08055002900355Velox ProMEDAX SRL UNIPERSONALEVP16160-002016-09-21
08055002900362Velox ProMEDAX SRL UNIPERSONALEVP16160-C02016-09-21
08055002900379Velox ProMEDAX SRL UNIPERSONALEVP16200-002016-09-21
08055002900386Velox ProMEDAX SRL UNIPERSONALEVP16200-C02016-09-21
08055002900393Velox ProMEDAX SRL UNIPERSONALEVP18060-002016-09-21
08055002900409Velox ProMEDAX SRL UNIPERSONALEVP18100-002016-09-21
08055002900416Velox ProMEDAX SRL UNIPERSONALEVP18100-C02016-09-21
08055002900423Velox ProMEDAX SRL UNIPERSONALEVP18160-002016-09-21
08055002900430Velox ProMEDAX SRL UNIPERSONALEVP18160-C02016-09-21
08055002900447Velox ProMEDAX SRL UNIPERSONALEVP18200-002016-09-21
08055002900454Velox ProMEDAX SRL UNIPERSONALEVP18200-C02016-09-21
08055002900461Velox ProMEDAX SRL UNIPERSONALEVP20060-002016-09-21
08055002900478Velox ProMEDAX SRL UNIPERSONALEVP20100-002016-09-21
08055002900485Velox ProMEDAX SRL UNIPERSONALEVP20100-C02016-09-21
08055002900492Velox ProMEDAX SRL UNIPERSONALEVP20160-002016-09-21
08055002900508Velox ProMEDAX SRL UNIPERSONALEVP20160-C02016-09-21
08055002900515Velox ProMEDAX SRL UNIPERSONALEVP20200-002016-09-21
08055002900522Velox ProMEDAX SRL UNIPERSONALEVP20200-C02016-09-21
08055002900942Velox ProMEDAX SRL UNIPERSONALEVP21100-002016-09-21
08055002900973Velox ProMEDAX SRL UNIPERSONALEVP21160-002016-09-21
08055002900980Velox ProMEDAX SRL UNIPERSONALEVP21100-C02016-09-21
08055002900997Velox ProMEDAX SRL UNIPERSONALEVP21160-C02016-09-21
08055002903691COX for BIO-FEATHERMEDAX SRL UNIPERSONALECB12100-002018-03-07
08055002903738COX for BIO-FEATHERMEDAX SRL UNIPERSONALECB14160-002018-03-07