FDA.reportPublic FDA data

Reusable Needle Guide for use with the Exact Imaging EV29L Transducer

Primary DI
00628055481089
Brand
Reusable Needle Guide for use with the Exact Imaging EV29L Transducer
Company
Exact Imaging Inc
Model
Single Unit
Catalog number
EV-BIOGR
Device description
The EV29L Reusable Needle Guide is a specially designed biopsy needle guide for use with the EV29L transducer.
Published
2018-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OIJBiopsy Needle Guide Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIJBiopsy Needle Guide KitRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180636000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180636000ExactVu High Resolution Micro-Ultrasound SystemExact Imaging, Inc.2018-04-30IYO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628055481089PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628055481089006280554810896280554810890628055481089

GMDN Terms#

Term, Definition table
TermDefinition
Nonimplantable needle guide, reusableA non-powered device designed to lead a needle into its proper course when performing a clinical and/or surgical procedure. Dedicated needle guides are available for many different procedures such as plastic guides for urethral injections, stainless steel guides for transrectal prostate biopsy, guides for ultrasound-guided percutaneous punctures and nerve blocks, guides for electromagnetic device tracking systems, and guides for stereotactic breast biopsies. This is a reusable device intended to be sterilized/disinfected prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
203044268
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628055481225EV29L Non-Sterile Reusable PrecisionPoint AdapterEV-BIOGR-PPEV-BIOGR-PP2025-05-05
00628055481058Needle Guide for use with the Exact Imaging EV29L TransducerSingle UnitEV-BIOG-12017-02-08
00628055481102Sterile transperineal needle guide with sheathSingle UnitEV-29L-TPK-12021-02-03
00628055481157Sterile transrectal needle guide with sheathSingle UnitEV-29L-TRK-12021-02-03
00628055481140Non-Sterile Reusable Needle Guide - 16GAEV-BIOG-R16EV-BIOG-R162022-05-13
00628055481096EV5C Abdominal TransducerEV5CEV-5C2021-02-03
10628055481116Sterile transperineal needle guide with sheathSingle UnitEV-29L-TPK-12021-02-03
10628055481161Sterile transrectal needle guide with sheathSingle UnitEV-29L-TRK-12021-02-03
20628055481076Needle Guide for use with the Exact Imaging EV29L TransducerSingle UnitEV-BIOG-12017-02-08
00628055481010ExactVu High Resolution Micro-Ultrasound System1.0EV-SYS-2202017-02-08
00628055481027ExactVu High Resolution Micro-Ultrasound System1.0EV-SYS-1202017-02-08
00628055481034EV29L Transrectal TransducerEV29LEV-29L2017-02-08
00628055481041EV9C Transrectal TransducerEV9CEV-9C2017-02-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975122554851MindrayJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2026-06-02
06975122554868MindrayJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2026-06-02
06975122554875MindrayJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2026-06-02
B201CGSG140Clear Guide SteriGRIDCLEAR GUIDE MEDICAL, INC.OIJ2026-05-11
06945868600471SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868603809SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
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06945868606053SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09