Consulting Wallah › Device Explorer › Other devices › Orbital depressor, reusable
Device Explorer · FDA GUDID · GMDN 16465

Orbital depressor, reusable

A hand-held ophthalmic surgical instrument designed for extra-orbital displacement of the sclera to facilitate examination/treatment of the surrounding area in the orbital cavity during eye surgery; it does not provide illumination. Sometimes referred to as a

US‑registered devices112in commercial distribution
Companies28labelers on GUDID
Single‑use2%of device records
Sterile0%labelled sterile
Prescription74%Rx‑only share
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Share of device records

Ambler Surgical Corp.2220%
Avalign Technologies, Inc.98%
Bausch & Lomb Incorporated87%
Steris Corporation76%
Aspen Surgical Products, Inc.54%
Novo Surgical, Inc.54%
Katena Products, Inc.54%
Wexler Surgical, Inc.54%

Top labelers

CompanyDevicesShare
Ambler Surgical Corp.2220%
Avalign Technologies, Inc.98%
Bausch & Lomb Incorporated87%
Steris Corporation76%
Aspen Surgical Products, Inc.54%
Novo Surgical, Inc.54%
Katena Products, Inc.54%
Wexler Surgical, Inc.54%
Sontec Instruments, Inc.54%
Aesculap, Inc.44%
Krishna Imports Inc44%
Med Saver, Inc.44%

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

Brand names on the register (sample)

Duckworth & KentINAMIInamiBerke-Jaeger Lid PlateAESCULAPMORIASymmetry O'ConnorSymmetry SchocketSymmetry FlynnSymmetry SchepensScleral DepressorNovo Surgical Inc.Orbit DepressorAnodyne SurgicalHayden MedicalBR Surgical, LLC

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

FDA product codes

CodeNameDevices
HNXDepressor, orbital37
HNXDepressor, Orbital36
HNIRetractor, ophthalmic25
MDMInstrument, Manual, Surgical, General Use6
HNIRetractor, Ophthalmic3
HNDSpatula, Ophthalmic3

GMDN & GCC registration

  • GMDN code 16465 · non‑implantable
  • Single‑use 2% · sterile 0% · Rx‑only 74% · OTC 3%
  • 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) · 3Width (Millimeter) · 1

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

How many orbital depressor, reusable products are registered in the US?

112 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orbital depressor, reusable", from 28 companies. The largest labeler is Ambler Surgical Corp. with 20% of records.

Which FDA product codes apply?

HNX (Depressor, orbital), HNX (Depressor, Orbital), HNI (Retractor, ophthalmic), MDM (Instrument, Manual, Surgical, General Use)

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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