Consulting Wallah › Device Explorer › Endoscopy & surgical instruments › Endoscope distal observation spacer, single-use
Device Explorer · FDA GUDID · GMDN 64014

Endoscope distal observation spacer, single-use

A short, light-penetrating cap designed to be placed onto the distal end of an endoscope (e.g., colonoscope) to facilitate observation, by retaining a short distance between the endoscope tip and lumen wall or other structure of interest. It typically has a sm

US‑registered devices73in commercial distribution
Companies5labelers on GUDID
Single‑use100%of device records
Sterile99%labelled sterile
Prescription86%Rx‑only share
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Share of device records

Olympus Medical Systems Corp.2838%
Micro-Tech (Nanjing) Co., Ltd.2636%
Finemedix Co.,Ltd.1419%
Keymed (Medical & Industrial Equipment) Limited45%
Neptune Medical Inc.11%

Top labelers

CompanyDevicesShare
Olympus Medical Systems Corp.2838%
Micro-Tech (Nanjing) Co., Ltd.2636%
Finemedix Co.,Ltd.1419%
Keymed (Medical & Industrial Equipment) Limited45%
Neptune Medical Inc.11%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Disposable Distal CapDISPOSABLE DISTAL ATTACHMENTPathfinder® Endoscope CapOlympusClearCap Distal Attachment

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

FDA product codes

CodeNameDevices
FDSGastroscope And Accessories, Flexible/Rigid45
OCXEndoscopic Irrigation/Suction System14
FDSGastroscope and accessories, flexible/rigid10
FDFColonoscope And Accessories, Flexible/Rigid8
FEDEndoscopic Access Overtube, Gastroenterology-Urology4
FTYTape, Measuring, Rulers And Calipers1

GMDN & GCC registration

  • GMDN code 64014 · non‑implantable
  • Single‑use 100% · sterile 99% · Rx‑only 86% · 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) · 26Outer Diameter (Millimeter) · 26Lumen/Inner Diameter (Millimeter) · 1Depth (Millimeter) · 1

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

How many endoscope distal observation spacer, single-use products are registered in the US?

73 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Endoscope distal observation spacer, single-use", from 5 companies. The largest labeler is Olympus Medical Systems Corp. with 38% of records.

Which FDA product codes apply?

FDS (Gastroscope And Accessories, Flexible/Rigid), OCX (Endoscopic Irrigation/Suction System), FDS (Gastroscope and accessories, flexible/rigid), FDF (Colonoscope And Accessories, Flexible/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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