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Device Explorer · FDA GUDID · GMDN 58248

Ultrasound imaging system tracking positioner, reusable

A metal or plastic bracket intended to be applied to a hand-held ultrasound (US) transducer for the repeatable positioning (detach from/reattach to same place) of an electromagnetic (EM) sensor and/or needle guide on the transducer. It may be used in conjuncti

US‑registered devices662in commercial distribution
Companies6labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription84%Rx‑only share
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Share of device records

Civco Medical Instruments Co., Inc.43065%
Protek Medical Products, Inc.13020%
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.6310%
Edan Instruments, Inc.213%
Canon Inc.152%
Fujifilm Corporation30%

Top labelers

CompanyDevicesShare
Civco Medical Instruments Co., Inc.43065%
Protek Medical Products, Inc.13020%
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.6310%
Edan Instruments, Inc.213%
Canon Inc.152%
Fujifilm Corporation30%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NGB-007 Needle-guided BracketNGB-011 Needle-guided BracketNGB-022 Needle-guided BracketNGB-018 Needle-guided BracketNGB-035 Needle-guided BracketNGB-039 Needle-guided BracketNGB-027 Needle-guided BracketNGB-040Needle-guided BracketNGB-036 Needle-guided BracketNGB-034 Needle-guided BracketNGB-026 Needle-guided BracketNGB-020 Needle-guided Bracket/VETNGB-018 Needle-guided Bracket/VETNGB-015 Needle-guided Bracket/VETNGB-011 Needle-guided Bracket/VETNGB-010 Needle-guided Bracket/VET

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
ITXTransducer, ultrasonic, diagnostic359
ITXTransducer, Ultrasonic, Diagnostic138
IYOSystem, imaging, pulsed echo, ultrasonic93
OIJBiopsy Needle Guide Kit39
IYNSystem, imaging, pulsed doppler, ultrasonic19
IYOSystem, Imaging, Pulsed Echo, Ultrasonic3

GMDN & GCC registration

  • GMDN code 58248 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 84% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Inch) · 287Height (Inch) · 182Width (Inch) · 105Length (Centimeter) · 6Width (Centimeter) · 5Height (Centimeter) · 1

Use these as the dimensions to specify in a tender line.

How many ultrasound imaging system tracking positioner, reusable products are registered in the US?

662 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ultrasound imaging system tracking positioner, reusable", from 6 companies. The largest labeler is Civco Medical Instruments Co., Inc. with 65% of records.

Which FDA product codes apply?

ITX (Transducer, ultrasonic, diagnostic), ITX (Transducer, Ultrasonic, Diagnostic), IYO (System, imaging, pulsed echo, ultrasonic), OIJ (Biopsy Needle Guide Kit)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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