Consulting Wallah › Device Explorer › Other devices › Optical proctoscope, reusable
Device Explorer · FDA GUDID · GMDN 35255

Optical proctoscope, reusable

An endoscope with a rigid inserted portion intended for the visual examination and treatment of the rectum and anus. It is inserted into the body through the anus during proctoscopy. The anatomical images are illuminated by a built-in or external light source

US‑registered devices64in commercial distribution
Companies10labelers on GUDID
Single‑use2%of device records
Sterile2%labelled sterile
Prescription47%Rx‑only share
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Share of device records

Ftt Medical, Inc.2844%
Rz-Medizintechnik Gmbh1828%
Karl Storz Gmbh & Co. Kg58%
Heine Optotechnik Gmbh & Co. Kg46%
Ambler Surgical Corp.35%
American Medicals23%
Aesculap Ag12%
Aspen Surgical Products, Inc.12%

Top labelers

CompanyDevicesShare
Ftt Medical, Inc.2844%
Rz-Medizintechnik Gmbh1828%
Karl Storz Gmbh & Co. Kg58%
Heine Optotechnik Gmbh & Co. Kg46%
Ambler Surgical Corp.35%
American Medicals23%
Aesculap Ag12%
Aspen Surgical Products, Inc.12%
Steris Corporation12%
Sapi Med Spa12%

Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

INSTRUMENT HEAD FOR UNISPEC TUBESHEINE® F.O. SigmoidoscopeHEINE® Proctoscope Head MaderHEINE® Proctoscope TubeRZ Medizintechnik GmbHn.a.AESCULAPSymmetry FANSLERAmbler SurgicalESIAmerican MedicalsV. MuellerRetractor

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

FDA product codes

CodeNameDevices
GCFProctoscope29
FFQSPECULUM, RECTAL20
GCMENDOSCOPE, RIGID10
GCMEndoscope, Rigid3
FXESPECULUM, NON-ILLUMINATED3
FERAnoscope And Accessories2

GMDN & GCC registration

  • GMDN code 35255 · non‑implantable
  • Single‑use 2% · sterile 2% · Rx‑only 47% · 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 (Millimeter) · 10Outer Diameter (Millimeter) · 9Angle (degree) · 1Length (Inch) · 1

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

How many optical proctoscope, reusable products are registered in the US?

64 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Optical proctoscope, reusable", from 10 companies. The largest labeler is Ftt Medical, Inc. with 44% of records.

Which FDA product codes apply?

GCF (Proctoscope), FFQ (SPECULUM, RECTAL), GCM (ENDOSCOPE, RIGID), GCM (Endoscope, Rigid)

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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