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Device Explorer · FDA GUDID · GMDN 37142

Endoscopic-access dilator, reusable

A device intended to be used to dilate a body lumen or access channel to facilitate the introduction of endoscopic instruments percutaneously (through the skin) or through a natural orifice (e.g., urethra). It may be a flexible or rigid rod/tube with a tapered

US‑registered devices446in commercial distribution
Companies26labelers on GUDID
Single‑use4%of device records
Sterile3%labelled sterile
Prescription78%Rx‑only share
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Share of device records

Joimax Gmbh7016%
Highridge Medical, Llc6314%
Life Spine, Inc.6013%
Arthrex, Inc.5412%
Karl Storz Gmbh & Co. Kg389%
Doppkon Gmbh & Co. Kg276%
Richard Wolf Gmbh266%
Integrity Implants Inc.204%

Top labelers

CompanyDevicesShare
Joimax Gmbh7016%
Highridge Medical, Llc6314%
Life Spine, Inc.6013%
Arthrex, Inc.5412%
Karl Storz Gmbh & Co. Kg389%
Doppkon Gmbh & Co. Kg276%
Richard Wolf Gmbh266%
Integrity Implants Inc.204%
Hoogland Spine Products Gmbh174%
Spinal Simplicity, Llc102%
Spineology Inc.92%
Well Lead Medical Co.,Ltd82%

Company = labeler of record on GUDID. 26 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Percutaneous Nephrostomy DilatorTROCAR INTRODUCER FOR LTF 5MM SCOPETROCAR INTRODUCER FOR LTF 5 MM SCOPEN/AMaxMoreSpineTrokamedGuiding Rod, conical, greenGuiding Rod, conicalGuiding rod, conical, longitudinal slantedGuiding rod , conicalGuiding Tube, conicalGuiding Tube, eccentrically cannulated, purpleGuiding Tube, eccentrically cannulated, redguiding rodguiding sleevecrown cutter

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

FDA product codes

CodeNameDevices
LXHOrthopedic manual surgical instrument84
LXHOrthopedic Manual Surgical Instrument55
FZXGuide, surgical, instrument53
NKBThoracolumbosacral pedicle screw system50
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT46
NBHAccessories, arthroscopic33

GMDN & GCC registration

  • GMDN code 37142 · non‑implantable
  • Single‑use 4% · sterile 3% · Rx‑only 78% · 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

Outer Diameter (Millimeter) · 28Lumen/Inner Diameter (Millimeter) · 19Length (Millimeter) · 6

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

How many endoscopic-access dilator, reusable products are registered in the US?

446 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Endoscopic-access dilator, reusable", from 26 companies. The largest labeler is Joimax Gmbh with 16% of records.

Which FDA product codes apply?

LXH (Orthopedic manual surgical instrument), LXH (Orthopedic Manual Surgical Instrument), FZX (Guide, surgical, instrument), NKB (Thoracolumbosacral pedicle screw system)

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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