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Device Explorer · FDA GUDID · GMDN 35351

Rectal speculum

A hand-held manual surgical instrument intended to be used to expand or stretch the rectal orifice/canal after it is inserted and opened. It is comprised of two arms joined at a pivot point and is available in various sizes, shapes, and contours; it is usually

US‑registered devices583in commercial distribution
Companies32labelers on GUDID
Single‑use4%of device records
Sterile0%labelled sterile
Prescription56%Rx‑only share
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Share of device records

Surtex Instruments Ltd.8715%
Avalign Technologies, Inc.6211%
Integra Lifesciences Production Corporation559%
Surgical Direct, Inc.519%
Hnm Stainless, Llc.397%
Hayden Medical, Inc.305%
Novo Surgical, Inc.285%
Ambler Surgical Corp.285%

Top labelers

CompanyDevicesShare
Surtex Instruments Ltd.8715%
Avalign Technologies, Inc.6211%
Integra Lifesciences Production Corporation559%
Surgical Direct, Inc.519%
Hnm Stainless, Llc.397%
Hayden Medical, Inc.305%
Novo Surgical, Inc.285%
Ambler Surgical Corp.285%
Sontec Instruments, Inc.264%
Elmed Incorporated193%
Sklar Corporation183%
Rz-Medizintechnik Gmbh142%

Company = labeler of record on GUDID. 32 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Eisenhammer Retractor with Ratchet, 180mm O/L, 8Eisenhammer Retractor, 180mm O/L, 80mm BladeSurtexSurgical SpeculumsEOSRZ Medizintechnik GmbHGimmin.a.AESCULAPMediconSPECULUMSymmetry Hinkle-JamesSymmetry BrinkerhoffSymmetry PrattSymmetry SimsSymmetry Hirschmann

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

FDA product codes

CodeNameDevices
FFQSPECULUM, RECTAL309
FFQSpeculum, Rectal133
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE41
FXESPECULUM, NON-ILLUMINATED22
MDMInstrument, Manual, Surgical, General Use17
FXESpeculum, Non-Illuminated15

GMDN & GCC registration

  • GMDN code 35351 · non‑implantable
  • Single‑use 4% · sterile 0% · Rx‑only 56% · 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 (Inch) · 12Length (Centimeter) · 11Width (Millimeter) · 8Outer Diameter (Millimeter) · 6Width (Inch) · 3Length (Millimeter) · 2

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

How many rectal speculum products are registered in the US?

583 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Rectal speculum", from 32 companies. The largest labeler is Surtex Instruments Ltd. with 15% of records.

Which FDA product codes apply?

FFQ (SPECULUM, RECTAL), FFQ (Speculum, Rectal), MDM (INSTRUMENT, MANUAL, SURGICAL, GENERAL USE), FXE (SPECULUM, NON-ILLUMINATED)

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.

How do I get quotes?

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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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