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Device Explorer · FDA GUDID · GMDN 11266

Fixed-diameter cervical dilator, reusable

A rod-like, solid surgical instrument designed to dilate the cervical canal after its insertion through the cervical os. Commonly known as a uterine dilator, it is typically made of metal or plastic material and has a tapered, rounded distal tip. It may have o

US‑registered devices1,578in commercial distribution
Companies28labelers on GUDID
Single‑use1%of device records
Sterile1%labelled sterile
Prescription76%Rx‑only share
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Share of device records

Surgical Direct, Inc.25916%
Avalign Technologies, Inc.20213%
Hayden Medical, Inc.18312%
Integra Lifesciences Production Corporation17311%
Medgyn Products, Inc.1379%
Schobell Industrial Ltda966%
Ambler Surgical Corp.896%
Steris Corporation654%

Top labelers

CompanyDevicesShare
Surgical Direct, Inc.25916%
Avalign Technologies, Inc.20213%
Hayden Medical, Inc.18312%
Integra Lifesciences Production Corporation17311%
Medgyn Products, Inc.1379%
Schobell Industrial Ltda966%
Ambler Surgical Corp.896%
Steris Corporation654%
Br Surgical, Llc543%
Gimmi Gmbh513%
Teleflex Incorporated443%
Aspen Surgical Products, Inc.423%

Company = labeler of record on GUDID. 28 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SurgicalRocketNARZ Medizintechnik GmbHGimmiAESCULAPHank dilator- Cervical dilator double endedCervical dilator set- PrattHEGAR DilatorCervical dilator- hankSymmetry SurgicalSymmetry GarrettSymmetry CooleySymmetry SarnsSymmetry GARRETTSymmetry Walther

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

FDA product codes

CodeNameDevices
HDQDILATOR, CERVICAL, FIXED SIZE758
HDQDilator, Cervical, Fixed Size491
EIGRETRACTOR, ALL TYPES245
DWPDilator, Vessel, Surgical29
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE14
EIGRetractor, All Types13

GMDN & GCC registration

  • GMDN code 11266 · non‑implantable
  • Single‑use 1% · sterile 1% · Rx‑only 76% · 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) · 92Catheter Gauge (French) · 45Length (Inch) · 43Length (Millimeter) · 29Circumference (Millimeter) · 17Length (Centimeter) · 15

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

How many fixed-diameter cervical dilator, reusable products are registered in the US?

1,578 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Fixed-diameter cervical dilator, reusable", from 28 companies. The largest labeler is Surgical Direct, Inc. with 16% of records.

Which FDA product codes apply?

HDQ (DILATOR, CERVICAL, FIXED SIZE), HDQ (Dilator, Cervical, Fixed Size), EIG (RETRACTOR, ALL TYPES), DWP (Dilator, Vessel, Surgical)

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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