FDA.reportPublic FDA data

Needle Guide for use with the Exact Imaging EV29L Transducer

Primary DI
00628055481058
Brand
Needle Guide for use with the Exact Imaging EV29L Transducer
Company
Exact Imaging Inc
Model
Single Unit
Catalog number
EV-BIOG-1
Device description
The EV29L Sterile Biopsy Needle Guide is a specially designed biopsy needle guide for use with the EV29L transducer.
Published
2017-02-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
K162972000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162972000ExactVu High Resolution Micro-Ultrasound SystemExact Imaging2016-12-02IYO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10628055481062PackageGS15In Commercial Distribution
20628055481076PackageGS124In Commercial Distribution
00628055481058PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1062805548106210628055481062
2062805548107620628055481076
00628055481058006280554810586280554810580628055481058

GMDN Terms#

Term, Definition table
TermDefinition
Needle guide, single-useA 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.

Regulatory Flags#

DUNS number
203044268
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
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
00628055481089Reusable Needle Guide for use with the Exact Imaging EV29L Transducer Single UnitEV-BIOGR2018-06-01
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
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