Device Explorer · FDA GUDID · GMDN 14339

Valvulotome

A hand-held manual surgical instrument designed for cutting an anatomical valve or valves in situ (e.g., to slit a heart valve or to cut the valves within a vein to allow blood flow in the opposite direction). It is typically a flexible, plastic-coated metal s

US‑registered devices55in commercial distribution
Companies11labelers on GUDID
Single‑use25%of device records
Sterile27%labelled sterile
Prescription89%Rx‑only share
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Share of device records

Teleflex Incorporated1629%
Lemaitre Vascular, Inc.1425%
Aspen Surgical Products, Inc.611%
Scanlan International Inc59%
Avalign Technologies, Inc.35%
Surgical Direct, Inc.35%
Steris Corporation35%
Geister Medizintechnik Gmbh24%

Top labelers

CompanyDevicesShare
Teleflex Incorporated1629%
Lemaitre Vascular, Inc.1425%
Aspen Surgical Products, Inc.611%
Scanlan International Inc59%
Avalign Technologies, Inc.35%
Surgical Direct, Inc.35%
Steris Corporation35%
Geister Medizintechnik Gmbh24%
Olympus Medical Systems Corp.12%
Aesculap, Inc.12%
Med Saver, Inc.12%

Company = labeler of record on GUDID. 11 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

VALVULOTOME (DETACHABLE TYPE)Valvulotome 23cm, blade 2mm, w/ballValvulotome 25cm, blade 2mm, w/ballAESCULAPSymmetry SurgicalSCANLAN® In Situ ValvulotomesAntegrade and Retrograde LeMills ValvulotomeAntegrade LeMills ValvulotomeRetrograde LeMills ValvulotomeHydro LeMaitre ValvulotomeExpandable LeMaitre ValvulotomeHYDRO LeMaitre ValvulotomeOver-the-Wire LeMaitre ValvulotomeMSI Precision Specialty InstrumentsMillenniumSurgical Direct

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

FDA product codes

CodeNameDevices
MGZValvulotome37
DWSINSTRUMENTS, SURGICAL, CARDIOVASCULAR19
DWXSTRIPPER, ARTERY, INTRALUMINAL2
MGZVALVULOTOME2
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE1
GAISTRIPPER, VEIN, REUSABLE1

GMDN & GCC registration

  • GMDN code 14339 · non‑implantable
  • Single‑use 25% · sterile 27% · Rx‑only 89% · 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) · 18Length (Centimeter) · 4

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

No closely related category with 50+ devices.

How many valvulotome products are registered in the US?

55 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Valvulotome", from 11 companies. The largest labeler is Teleflex Incorporated with 29% of records.

Which FDA product codes apply?

MGZ (Valvulotome), DWS (INSTRUMENTS, SURGICAL, CARDIOVASCULAR), DWX (STRIPPER, ARTERY, INTRALUMINAL), MGZ (VALVULOTOME)

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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