Consulting Wallah › Device Explorer › Other devices › Comedo expressor
Device Explorer · FDA GUDID · GMDN 57817

Comedo expressor

A manual instrument designed for pressing or squeezing out a comedo (black head) from the mouth of sebaceous follicles. It typically consists of a hand-held device with one or both ends appropriately configured (e.g., crimped, spoon-like, forming loops) for th

US‑registered devices128in commercial distribution
Companies16labelers on GUDID
Single‑use0%of device records
Sterile1%labelled sterile
Prescription38%Rx‑only share
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Share of device records

George Tiemann & Co.2923%
Marina Medical Instruments, Inc.2016%
Hayden Medical, Inc.119%
Br Surgical, Llc108%
Sontec Instruments, Inc.86%
Integra Lifesciences Production Corporation86%
Sklar Corporation75%
Gsource Llc65%

Top labelers

CompanyDevicesShare
George Tiemann & Co.2923%
Marina Medical Instruments, Inc.2016%
Hayden Medical, Inc.119%
Br Surgical, Llc108%
Sontec Instruments, Inc.86%
Integra Lifesciences Production Corporation86%
Sklar Corporation75%
Gsource Llc65%
Teleflex Incorporated65%
Novo Surgical, Inc.65%
Medicon Eg. Chirurgiemechaniker-Genossenschaft43%
Van Sickle Surgical Instruments, Incorporated43%

Company = labeler of record on GUDID. 16 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

MediconHayden MedicalgSourceMarina MedicalBR Surgical, LLCVan SickleMcKessonMSI Precision Specialty InstrumentsComedone ExtractorSONTEC-UNNA COMEDONE EXTRACTORSAALFIELD COMEDONE EXTRACTORSCHAMBERG COMEDONEEXTRACTORSAALFIELD COMEDONEEXTRACTORN/AAmerican MedicalsKMEDIC

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

FDA product codes

CodeNameDevices
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE33
HNSExpressor29
KALRETRACTOR, ENT20
FZSCURETTE, SURGICAL, GENERAL USE16
MDMInstrument, Manual, Surgical, General Use13
FZSCurette, Surgical, General Use12

GMDN & GCC registration

  • GMDN code 57817 · non‑implantable
  • Single‑use 0% · sterile 1% · Rx‑only 38% · 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 (Centimeter) · 11Length (Inch) · 8Length (Millimeter) · 1

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

How many comedo expressor products are registered in the US?

128 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Comedo expressor", from 16 companies. The largest labeler is George Tiemann & Co. with 23% of records.

Which FDA product codes apply?

MDM (INSTRUMENT, MANUAL, SURGICAL, GENERAL USE), HNS (Expressor), KAL (RETRACTOR, ENT), FZS (CURETTE, 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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