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
1,263
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00628055481058Needle Guide for use with the Exact Imaging EV29L TransducerExact Imaging IncSingle Unit2017-02-08
00628055481102Sterile transperineal needle guide with sheathExact Imaging IncSingle Unit2021-02-03
00628055481157Sterile transrectal needle guide with sheathExact Imaging IncSingle Unit2021-02-03
00749756908207DeRoyalDEROYAL INDUSTRIES, INC.28-10012021-07-28
00801741037771Site-RiteBard Access Systems, Inc.900013B012016-09-16
00801741037818Site-RiteBard Access Systems, Inc.9001C02122016-09-14
00801741037825Site-RiteBard Access Systems, Inc.9001C02142016-09-14
00801741079382VACORA®Bard Peripheral Vascular, Inc.VBB27CY2016-09-20
00801741079399VACORA®Bard Peripheral Vascular, Inc.VBB27GE2016-09-20
00801741079405VACORA®Bard Peripheral Vascular, Inc.VBB27LO2016-09-20
00801741079412VACORA®Bard Peripheral Vascular, Inc.VBB27MA2016-09-20
00801741079429VACORA®Bard Peripheral Vascular, Inc.VBB27SI2016-09-20
00801741079436VACORA®Bard Peripheral Vascular, Inc.VBB40CY2016-09-20
00801741079443VACORA®Bard Peripheral Vascular, Inc.VBB40GE2016-09-20
00801741079450VACORA®Bard Peripheral Vascular, Inc.VBB40LO2016-09-20
00801741079467VACORA®Bard Peripheral Vascular, Inc.VBB40MA2016-09-20
00801741079474VACORA®Bard Peripheral Vascular, Inc.VBB40SI2016-09-20
00801741079481VACORA®Bard Peripheral Vascular, Inc.VBB45CY2016-09-20
00801741079498VACORA®Bard Peripheral Vascular, Inc.VBB45GE2016-09-20
00801741079504VACORA®Bard Peripheral Vascular, Inc.VBB45LO2016-09-20
00801741079511VACORA®Bard Peripheral Vascular, Inc.VBB45MA2016-09-20
00801741079528VACORA®Bard Peripheral Vascular, Inc.VBB45SI2016-09-20
00801741079559VACORA®Bard Peripheral Vascular, Inc.VC101182016-09-21
00801741079566VACORA®Bard Peripheral Vascular, Inc.VC10118MRS2016-09-21
00801741079573VACORA®Bard Peripheral Vascular, Inc.VC10118P2016-09-21
00801741079580VACORA®Bard Peripheral Vascular, Inc.VC101402016-09-21
00801741079597VACORA®Bard Peripheral Vascular, Inc.VC10140MRS2016-09-21
00801741079603VACORA®Bard Peripheral Vascular, Inc.VC10140P2016-09-21
00801741079610VACORA®Bard Peripheral Vascular, Inc.VC141162016-09-20
00801741079627VACORA®Bard Peripheral Vascular, Inc.VC14116MRS2016-09-20
00801741079634VACORA®Bard Peripheral Vascular, Inc.VC14116P2016-09-20
00801741079641VACORA®Bard Peripheral Vascular, Inc.VC141382016-09-20
00801741079658VACORA®Bard Peripheral Vascular, Inc.VC14138MRS2016-09-20
00801741079665VACORA®Bard Peripheral Vascular, Inc.VC14138P2016-09-20
00801741079849BARD®Bard Peripheral Vascular, Inc.485002016-09-13
00801741079856BARD®Bard Peripheral Vascular, Inc.487002016-09-13
00801741079863BARD®Bard Peripheral Vascular, Inc.489002016-09-13
00801741083921FINESSE®Bard Peripheral Vascular, Inc.FS101052016-09-20
00801741083938FINESSE®Bard Peripheral Vascular, Inc.FS141052016-09-20
00801741084805BARD®Bard Peripheral Vascular, Inc.AX14102016-09-13
00801741084812BARD®Bard Peripheral Vascular, Inc.AX14132016-09-13
00801741084829BARD®Bard Peripheral Vascular, Inc.AX14162016-09-13
00801741084836TRUGUIDEBard Peripheral Vascular, Inc.C1210A2016-09-15
00801741084843TRUGUIDEBard Peripheral Vascular, Inc.C1210B2016-09-15
00801741084850TRUGUIDEBard Peripheral Vascular, Inc.C1213B2016-09-15
00801741084867TRUGUIDEBard Peripheral Vascular, Inc.C1216A2016-09-15
00801741084874TRUGUIDEBard Peripheral Vascular, Inc.C1216B2016-09-15
00801741084881TRUGUIDEBard Peripheral Vascular, Inc.C1410A2016-09-15
00801741084898TRUGUIDEBard Peripheral Vascular, Inc.C1410B2016-09-15
00801741084904TRUGUIDEBard Peripheral Vascular, Inc.C1413B2016-09-15
00801741084911TRUGUIDEBard Peripheral Vascular, Inc.C1416A2016-09-15
00801741084928TRUGUIDEBard Peripheral Vascular, Inc.C1416B2016-09-15
00801741084935TRUGUIDEBard Peripheral Vascular, Inc.C1610A2016-09-15
00801741084942TRUGUIDEBard Peripheral Vascular, Inc.C1610B2016-09-15
00801741084959TRUGUIDEBard Peripheral Vascular, Inc.C1613B2016-09-15
00801741084966TRUGUIDEBard Peripheral Vascular, Inc.C1616A2016-09-15
00801741084973TRUGUIDEBard Peripheral Vascular, Inc.C1616B2016-09-15
00801741084980TRUGUIDEBard Peripheral Vascular, Inc.C1620A2016-09-15
00801741084997TRUGUIDEBard Peripheral Vascular, Inc.C1620B2016-09-15
00801741085000TRUGUIDEBard Peripheral Vascular, Inc.C1810A2016-09-15
00801741085017TRUGUIDEBard Peripheral Vascular, Inc.C1810B2016-09-15
00801741085024TRUGUIDEBard Peripheral Vascular, Inc.C1813B2016-09-15
00801741085031TRUGUIDEBard Peripheral Vascular, Inc.C1816A2016-09-15
00801741085048TRUGUIDEBard Peripheral Vascular, Inc.C1816B2016-09-15
00801741085055TRUGUIDEBard Peripheral Vascular, Inc.C1820A2016-09-15
00801741085062TRUGUIDEBard Peripheral Vascular, Inc.C1820B2016-09-15
00801741085079TRUGUIDEBard Peripheral Vascular, Inc.C2010A2016-09-15
00801741085086TRUGUIDEBard Peripheral Vascular, Inc.C2010B2016-09-15
00801741085093TRUGUIDEBard Peripheral Vascular, Inc.C2013B2016-09-15
00801741085109TRUGUIDEBard Peripheral Vascular, Inc.C2016A2016-09-15
00801741085116TRUGUIDEBard Peripheral Vascular, Inc.C2016B2016-09-15
00801741085123TRUGUIDEBard Peripheral Vascular, Inc.C2020A2016-09-15
00801741085130TRUGUIDEBard Peripheral Vascular, Inc.C2020B2016-09-15
00801741085208BARD®Bard Peripheral Vascular, Inc.GL12002016-09-15
00801741085215BARD®Bard Peripheral Vascular, Inc.GL14162016-09-15
00801741085222BARD®Bard Peripheral Vascular, Inc.GL18202016-09-15
00801741109119Pinpoint GT Needle Guide KitBard Access Systems, Inc.97706902017-10-09
00801741109126Pinpoint GT Needle Guide KitBard Access Systems, Inc.97706912017-10-09
00801741138171Pinpoint GT Needle Guide KitBard Access Systems, Inc.97706922017-10-09
00801741138188Pinpoint GT Needle Guide KitBard Access Systems, Inc.97706932017-10-09