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Device Explorer · FDA GUDID · GMDN 45198

ENT stereotactic surgery system

An assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during ear/nose/throat (ENT) surger

US‑registered devices81in commercial distribution
Companies5labelers on GUDID
Single‑use12%of device records
Sterile9%labelled sterile
Prescription99%Rx‑only share
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Share of device records

Medtronic Navigation, Inc.7289%
Fiagon Gmbh45%
Smith & Nephew, Inc.34%
Aesculap, Inc.11%
Exactech, Inc.11%

Top labelers

CompanyDevicesShare
Medtronic Navigation, Inc.7289%
Fiagon Gmbh45%
Smith & Nephew, Inc.34%
Aesculap, Inc.11%
Exactech, Inc.11%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

VirtuEye ProVirtuEyeFlexTube 3 single useFlexPointer 1.5 single useAESCULAPPyroCarbon PIP Total Joint SystemNuGrip CMCAscension MCP Joint ReplacementeNV™N/ANAStealthStation S8LandmarXSteathStationStealthStationMedtronic Navigation

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

FDA product codes

CodeNameDevices
PGWEar, Nose, and Throat Stereotaxic Instrument42
HAWNeurological stereotaxic Instrument40
PGWEar, Nose, And Throat Stereotaxic Instrument6
OLOOrthopedic stereotaxic instrument6
HTZINSTRUMENT, CUTTING, ORTHOPEDIC3
HABSAW, POWERED, AND ACCESSORIES3

GMDN & GCC registration

  • GMDN code 45198 · non‑implantable
  • Single‑use 12% · sterile 9% · Rx‑only 99% · 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

No structured size data on the register.

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

How many ent stereotactic surgery system products are registered in the US?

81 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "ENT stereotactic surgery system", from 5 companies. The largest labeler is Medtronic Navigation, Inc. with 89% of records.

Which FDA product codes apply?

PGW (Ear, Nose, and Throat Stereotaxic Instrument), HAW (Neurological stereotaxic Instrument), PGW (Ear, Nose, And Throat Stereotaxic Instrument), OLO (Orthopedic stereotaxic instrument)

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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