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Device Explorer · FDA GUDID · GMDN 38835

Surgical instrument/endoscope cleaning utensil, single-use

A non-absorbent, non-powered, hand-held device in the form of a brush, a wire, strip of metal, or handle intended to clean the exterior and/or interior (lumen) of a surgical instrument (e.g., bur, reamer, bone tap, suturing device, sheath/shaft, ultrasonic sur

US‑registered devices865in commercial distribution
Companies49labelers on GUDID
Single‑use99%of device records
Sterile7%labelled sterile
Prescription34%Rx‑only share
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Share of device records

Hangzhou Ags Medtech Co., Ltd.11613%
Key Surgical, Inc.9111%
Batrik Medical Manufacturing Inc789%
Aspen Surgical Products, Inc.627%
Primed Instruments Inc465%
Cygnus Medical L.L.C.445%
Healthmark Industries Co., Inc.364%
Ruhof Corporation334%

Top labelers

CompanyDevicesShare
Hangzhou Ags Medtech Co., Ltd.11613%
Key Surgical, Inc.9111%
Batrik Medical Manufacturing Inc789%
Aspen Surgical Products, Inc.627%
Primed Instruments Inc465%
Cygnus Medical L.L.C.445%
Healthmark Industries Co., Inc.364%
Ruhof Corporation334%
Richard Wolf Gmbh283%
Avanos Medical, Inc.273%
F.R.Galantai Manufacturing Company Limited263%
Sharn Anesthesia243%

Company = labeler of record on GUDID. 49 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

TL10Cleaning BrushDisposable Cleaning BrushNADual Ended Push-Pull Cleaning BrushSingle Use Cleaning BrushDisposable Dilator BrushN/APENTAX MedicalPENTAXSingle Use Soft BrushSingle Use Single-ended Cleaning Brush BW-403BSingle Use Single-ended Cleaning BrushSingle Use Channel-Opening Cleaning BrushSingle Use Combination Cleaning BrushAir/Water Channel Cleaning Adapter

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

FDA product codes

CodeNameDevices
MNLAccessories, Cleaning Brushes, For Endoscope660
MNLACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE230
FLGCleaner, Ultrasonic, Medical Instrument33
FFYAdaptor, Bulbs, Miscellaneous, For Endoscope18
FDXendoscopic cytology brush16
GCJLaparoscope, General & Plastic Surgery11

GMDN & GCC registration

  • GMDN code 38835 · non‑implantable
  • Single‑use 99% · sterile 7% · Rx‑only 34% · OTC 5%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Outer Diameter (Millimeter) · 41Length (Millimeter) · 34Length (Centimeter) · 22Width (Millimeter) · 17Outer Diameter (Inch) · 11Shaft Length (Millimeter) · 4

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

How many surgical instrument/endoscope cleaning utensil, single-use products are registered in the US?

865 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical instrument/endoscope cleaning utensil, single-use", from 49 companies. The largest labeler is Hangzhou Ags Medtech Co., Ltd. with 13% of records.

Which FDA product codes apply?

MNL (Accessories, Cleaning Brushes, For Endoscope), MNL (ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE), FLG (Cleaner, Ultrasonic, Medical Instrument), FFY (Adaptor, Bulbs, Miscellaneous, For Endoscope)

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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